ContraceptionPhase 3NCT00764881
Effects of SH T00658ID on Libido
A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658ID) and Microgynon in people with Contraception and Libido, run by Bayer at 32 sites in 7 countries.
Trial summary
The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Contraception, Libido
- What is being tested?
- EV/DNG (Qlaira, BAY86-5027, SH T00658ID) and Microgynon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 32 sitesin 7 countries
- Study dates
- Jan 2009to Jul 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
- Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline
Who cannot join
- Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
Austria7 sites
Ordination Dr.Hohlweg
Graz, Styria, 8010
Ordination Dr. Schaffer
Graz, Styria, 8044
Ordination Dr. Schmidl-Amann
Sankt Pölten, Lower Austria, 3100
Clin Pharm International GmbH Studienzentrum Wien
Vienna, State of Vienna, 1090
Dr. Brigitte Wiesenthal
Vienna, 1070
Dr. Wolfgang Bartl
Vienna, 1200
Dr. Walter Paulik
Zeltweg, 8740
Australia6 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Sydney Centre for Reproductive Health Reseach
Ashfield, New South Wales, 2031
Queen Elizabeth II Medical Centre
Nedlands, Western Australia, 6009
The Alfred Hospital
Prahran, Victoria, 3121
King Edward Memorial Hospital
Subiaco, Western Australia, 6008
Royal Hospital for Women
Sydney, New South Wales, 2031
Spain5 sites
Centro de Planificacion Familiar Alicante 3
Alicante, Alicante, 03013
USP Institut Universitari Dexeus
Barcelona, Barcelona, 08028
Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues
Gavà, Barcelona, 08850
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, 28009
Germany4 sites
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Praxis Dr. A. Schwenkhagen-Stodieck
Hamburg, Free and Hanseatic City of Hamburg, 20357
Frauenarztpraxis Dr. Bernd Pittner
Leipzig, Saxony, 04207
Italy4 sites
A.O.U. Policlinico - Vittorio Emanuele
Catania, 95123
A.O.U. di Cagliari
Monserrato, Cagliari, 09124
IRCCS Fondazione Maugeri - Montescano (Pavia)
Pavia, 27100
A.O.U. Pisana
Pisa, 56126
Belgium3 sites
Hôpital Erasme/Erasmus Ziekenhuis
Bruxelles - Brussel, 1070
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000
Thailand3 sites
Chulalongkorn Hospital
Bangkok, 10330
Ramathibodhi Hospital
Bangkok, 10400
Siriraj Hospital, Mahidol
Bangkok, 10700
About this study
Official title: Multi-center, Double-blind, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive Containing Estradiol Valerate and Dienogest (SH T00658ID) Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon) Over 6 Treatment Cycles on Alleviating Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With Oral Contraceptive Use
The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.
- Conditions
- Contraception, Libido
- Being tested
- EV/DNG (Qlaira, BAY86-5027, SH T00658ID), Microgynon, Placebo
- Keywords
- Oral contraceptive, Sexual dysfunction, Libido
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV/DNG (Qlaira, BAY86-5027, SH T00658ID)Drug
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose
MicrogynonDrug
Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.
PlaceboDrug
Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | Experimental | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles. Receives: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) |
| EE/LNG (Microgynon) + Placebo | Active comparator | Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles. Receives: Drug: Microgynon; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)
Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)
Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
Secondary outcomes (108)
The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline
Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).
Measured: At Baseline
The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6
Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)
Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline
Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
Measured: At Baseline
The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6
Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)
Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline
Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
Measured: At Baseline
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6
Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)
Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline
Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
Measured: At Baseline
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6
Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)
Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline
Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).
Measured: At Baseline
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6
Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)
Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.
Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
Measured: At Baseline
The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6
Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)
Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Total Score at Baseline
The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).
Measured: At Baseline
The Mean Absolute Values of FSFI Total Score at Cycle 6
The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Total Score
The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline
Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).
Measured: At Baseline
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6
Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score
Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline
Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).
Measured: At Baseline
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6
Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline
The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant
Measured: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6
The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score
Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline
Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6
Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety
Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline
Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6
Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood
Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline
Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6
Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being
Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline
Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6
Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control
Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline
General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6
General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health
General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline
Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6
Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Measured: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality
Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Measured: At Cycle 6 (28 days per Cycle)
Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Measured: At Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by Vaginal pH at Cycle 6
Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick
Measured: At Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline
ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).
Measured: At Baseline
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6
ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).
Measured: At Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)
ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline
The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).
Measured: At Baseline
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6
The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).
Measured: At Cycle 6 (28 days per Cycle)
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)
The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).
Measured: Baseline up to Cycle 6 (28 days per Cycle)
Number of Bleeding / Spotting Days in Reference Period 1
Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Measured: From Day 1 to Day 90
Number of Bleeding / Spotting Days in Reference Period 2
Reference Period 2 is defined as Day 91 to 180 during study treatment
Measured: From Day 91 to Day 180
Number of Bleeding / Spotting Episodes in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes
Measured: From Day 1 to Day 90
Number of Bleeding / Spotting Episodes in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment
Measured: From Day 91 to Day 180
Mean Length of Bleeding / Spotting Episodes in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes
Measured: From Day 1 to Day 90
Mean Length of Bleeding / Spotting Episodes in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Measured: From Day 91 to Day 180
Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Measured: From Day 1 to Day 90
Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Measured: From Day 91 to Day 180
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Measured: From Day 1 to Day 90
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Measured: From Day 91 to Day 180
Number of Spotting Only Days in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Measured: From Day 1 to Day 90
Number of Spotting Only Days in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Measured: From Day 91 to Day 180
Number of Spotting Only Episodes in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Measured: From Day 1 to Day 90
Number of Spotting Only Episodes in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Measured: From Day 91 to Day 180
Mean Length of Spotting-only Episodes in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Measured: From Day 1 to Day 90
Mean Length of Spotting-only Episodes in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Measured: From Day 91 to Day 180
Maximum Length of Spotting-only Episodes in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Measured: From Day 1 to Day 90
Maximum Length of Spotting-only Episodes in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Measured: From Day 91 to Day 180
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Measured: From Day 1 to Day 90
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Measured: From Day 91 to Day 180
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Measured: At Cycle 1 (28 days per Cycle)
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Measured: At Cycle 3 (28 days per Cycle)
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Measured: At Cycle 6 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 1
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Measured: At Cycle 1 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 3
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Measured: At Cycle 3 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 6
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Measured: At Cycle 6 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Measured: At Cycle 1 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Measured: At Cycle 3 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Measured: At Cycle 6 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
Measured: At Cycle 1 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
Measured: At Cycle 3 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
Measured: At Cycle 6 (28 days per Cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 1
Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
Measured: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1
Onset of Withdrawal Bleeding Episodes at Cycle 3
Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
Measured: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3
Onset of Withdrawal Bleeding Episodes at Cycle 6
Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
Measured: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 1 (28 days per Cycle)
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 3 (28 days per Cycle)
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 6 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 1 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 3 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 6
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 6 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 1 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 3 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 6 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 1
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 1 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 3
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 3 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 6
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: At Cycle 6 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.
Measured: At Cycle 1 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.
Measured: At Cycle 3 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.
Measured: At Cycle 6 (28 days per Cycle)
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Measured: Up to Cycle 6 (28 days per Cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764881
- Sponsor's protocol ID
- 91548
- Other IDs
- 2008-002263-13, 310785, 2008
- Status last verified
- Dec 2014
- First submitted
- 1 Oct 2008
- Last updated
- 30 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Davis SR, Bitzer J, Giraldi A, Palacios S, Parke S, Serrani M, Mellinger U, Nappi RE. Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. J Sex Med. 2013 Dec;10(12):3069-79. doi: 10.1111/jsm.12310. Epub 2013 Sep 12.
PubMed 24034466
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive Containing Estradiol Valerate and Dienogest (SH T00658ID) Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon) Over 6 Treatment Cycles on Alleviating Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With Oral Contraceptive Use
- ClinicalTrials.gov ID
- NCT00764881
- Acronym / sponsor ID
- 91548
- Conditions
- Contraception, Libido
- Keywords
- Oral contraceptive, Sexual dysfunction, Libido
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 3 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | Experimental | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles. |
| EE/LNG (Microgynon) + Placebo | Active comparator | Drug: Microgynon, Drug: PlaceboDaily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
- Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline
Key exclusion criteria (1 listed)
- Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027, SH T00658ID)Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose | Drug | EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) |
| MicrogynonDays 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles. | Drug | EE/LNG (Microgynon) + Placebo |
| PlaceboDays 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles. | Drug | EE/LNG (Microgynon) + Placebo |
Primary outcome
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).
108 secondary outcomes
The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline
Time frame: At Baseline
The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline
Time frame: At Baseline
The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline
Time frame: At Baseline
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline
Time frame: At Baseline
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline
Time frame: At Baseline
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.
Time frame: At Baseline
The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of FSFI Total Score at Baseline
Time frame: At Baseline
The Mean Absolute Values of FSFI Total Score at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in FSFI Total Score
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline
Time frame: At Baseline
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline
Time frame: At Baseline
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline
Time frame: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline
Time frame: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline
Time frame: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline
Time frame: At Baseline
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6
Time frame: At Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being
Time frame: Baseline up to Cycle 6 (28 days per Cycle)
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline
Time frame: At Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24034466Davis SR, Bitzer J, Giraldi A, Palacios S, Parke S, Serrani M, Mellinger U, Nappi RE. Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. J Sex Med. 2013 Dec;10(12):3069-79. doi: 10.1111/jsm.12310. Epub 2013 Sep 12.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658ID) and Microgynon in people with Contraception and Libido, run by Bayer at 32 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Austria, Australia, Spain, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS) (time frame: Baseline up to Cycle 6 (28 days per Cycle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.