Contraceptive, Oral, HormonalPhase 2NCT00653614
Cycle Control and Safety of E2-DRSP
A Phase 2 study testing E2/DRSP (BAY 86-4891) dose 1 (SH T04984E), E2/DRSP (BAY 86-4891) dose 2 (80458739) and E2/DRSP (BAY 86-4891) dose 3 (80458755) in people with Contraceptive, Oral, Hormonal, run by Bayer at 25 sites in Germany.
Trial summary
The study will be performed as a multi-center, randomized, double-blind, parallel-group trial in fertile women aged between 18 and 35 years inclusive. A total of 600 volunteers will be randomized into one of the six treatment groups. The study will be performed only in Germany. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Contraceptive, Oral, Hormonal
- What is being tested?
- E2/DRSP (BAY 86-4891) dose 1 (SH T04984E), E2/DRSP (BAY 86-4891) dose 2 (80458739) and E2/DRSP (BAY 86-4891) dose 3 (80458755)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 635 participants
- Where
- 25 sitesGermany
- Study dates
- Mar 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy female volunteers
- Age: 18 - 35 years (inclusive), smokers must not be older than 30 years at inclusion
- History of regular cyclic menstrual periods (with a cycle length between 25 and 35 days)
- Willingness to use barrier methods of contraception (condoms with spermicide, diaphragms with spermicide, spermicidal vaginal suppositories) or abstinence during the trial
Who cannot join
- Pregnancy, lactation (less than three menstrual cycles before Visit 1 following delivery, abortion, or lactation) - Obesity (BMI > 30.0 kg/m2)
- Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at Visit 1 or a normal result has to be documented within the last 6 months before Visit 1)
- Laboratory values outside inclusion range at Screening - Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results, as e.g.: - Cardiovascular -- presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g., transient ischemic attack, angina pectoris) and conditions which could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. -- uncontrolled arterial hypertension (repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
- Liver -- presence or history of liver tumor (benign or malignant) -- presence or history of severe hepatic disease as long as liver function values have not returned to normal -- jaundice and/or pruritus related to cholestasis -- history of cholestatic jaundice associated with pregnancy or previous COC use
- Metabolic diseases -- uncontrolled diabetes mellitus with vascular involvement severe dyslipoproteinemia
- Other diseases: any known or suspected malignant or premalignant disease, uncontrolled thyroid disorder, chronic inflammatory bowel disease, severe renal insufficiency or acute renal failure, hemolytic uremic syndrome, sickle cell anemia, porphyria, history of hypertriglyceridemia-associated Pancreatitis, systemic lupus erythematodes, pemphigoid gestationis during a previous pregnancy, Sydenham chorea, herpes gestationis, otosclerosis-related hearing loss, history of migraine with focal neurologic symptoms, epilepsy, current or history of clinically significant depression, hereditary angioedema
- Additional sex steroids, other hormonal contraceptive methods (oral, transdermal) during treatment (blister in use at randomization should be finished); intra-uterine devices (IUD) with or without hormone release within 1 month prior to Visit 1, implants within 1 month prior Visit 1, depot progestins within 6 months prior to Visit 1 - Surgical interventions scheduled in the study period
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Germany25 sites
Study site
Berlin, State of Berlin, 10247
Study site
Berlin, State of Berlin, 12587
Study site
Berlin, State of Berlin, 13086
Study site
Berlin, State of Berlin, 13507
Study site
Blankenburg, Saxony-Anhalt, 38889
Study site
Burg, Saxony-Anhalt, 39288
Study site
Dietzenbach, Hesse, 63128
Study site
Dippoldiswalde, Saxony, 01744
Study site
Dresden, Saxony, 01099
Study site
Dresden, Saxony, 01169
Study site
Frankfurt am Main, Hesse, 60322
Study site
Frankfurt am Main, Hesse, 65936
Study site
Fulda, Hesse, 36037
Study site
Gera, Thuringia, 07545
Study site
Hamburg, Free and Hanseatic City of Hamburg, 21073
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22159
Study site
Jessen, Saxony-Anhalt, 06917
Study site
Krumbach, Bavaria, 86381
Study site
Leipzig, Saxony, 04207
Study site
Leipzig, Saxony, 04299
Study site
Magdeburg, Saxony-Anhalt, 39104
Study site
Magdeburg, Saxony-Anhalt, 39126
Study site
Mühlheim am Main, Hesse, 63165
Study site
Nuremberg, Bavaria, 90491
Study site
Wurzen, Saxony, 04808
About this study
Official title: A Multi-center, Double-blind, Randomized, Parallel-group Study to Evaluate Cycle Control and Safety of 6 Different Regimens of an Oral Contraceptive Containing Estradiol and Drospirenone in Healthy Female Volunteers Aged Between 18 and 35 Years Over 7 Cycles
The study will be performed as a multi-center, randomized, double-blind, parallel-group trial in fertile women aged between 18 and 35 years inclusive. A total of 600 volunteers will be randomized into one of the six treatment groups. The study will be performed only in Germany. The investigational drug is an oral contraceptive. It contains the estrogen estradiol (E2) and the progestogen drospirenone (DRSP). As the contraceptive efficacy has not yet been proven for these new regimens, even a protection against unwanted pregnancies cannot be assured. The treatments will be applied daily for 7 cycles of 28 days each without pill-free interval, i.e., for 196 consecutive days. Treatment will be initiated after a screening period of approximately 1 to 2 weeks, the latter focused on confirmation of the baseline safety status. Tablet intake will start on the first day of the first menstrual/withdrawal bleeding after Visit 2, regardless of whether the volunteer is a first user (starter) or switching from another COC. In the following cycles, tablet intake is not to be triggered by any bleeding events. The primary objective of this study is to evaluate and compare the cycle control and bleeding patterns of six different treatment regimens with E2/DRSP during administration for 7 treatment cycles. Volunteers will be provided with a diary to document the intake of study medication, any bleeding events, and days without bleeding, pregnancy test results. Safety will be also assessed. During the whole study period, 4 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breast palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.Additional examinations can be performed any time, if this becomes necessary for medical reasons. At Visit 3 or in case of premature discontinuation of study the investigator will discuss options for follow-up contraception with the volunteer. The volunteer can start the intake of a post-treatment OC on the day after the last tablet intake of study medication, after a negative urine ß-HCG test (home pregnancy test) result.
- Conditions
- Contraceptive, Oral, Hormonal
- Being tested
- E2/DRSP (BAY 86-4891) dose 1 (SH T04984E), E2/DRSP (BAY 86-4891) dose 2 (80458739), E2/DRSP (BAY 86-4891) dose 3 (80458755), E2/DRSP (BAY 86-4891) dose 4 (80458720), E2/DRSP (BAY 86-4891) dose 5 (80458712)
- Keywords
- Oral contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)Drug
Single dose administration of E2 + DRSP as a tablet
E2/DRSP (BAY 86-4891) dose 2 (80458739)Drug
Single dose administration of E2 + DRSP as a tablet
E2/DRSP (BAY 86-4891) dose 3 (80458755)Drug
Single dose administration of E2 + DRSP as a tablet
E2/DRSP (BAY 86-4891) dose 4 (80458720)Drug
Single dose administration of E2 + DRSP as a tablet
E2/DRSP (BAY 86-4891) dose 5 (80458712)Drug
Single dose administration of E2 + DRSP as a tablet
DRSP (ZK 30595) dose 1 (SH T04984F)Drug
Single dose administration of DRSP as a tablet
DRSP (ZK 30595) dose 2 (80458690)Drug
Single dose administration of DRSP as a tablet
PlaceboDrug
Placebo administration in each arm
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for one day and placebo for three days in a 28 day cycle Receives: Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E); Drug: DRSP (ZK 30595) dose 1 (SH T04984F); Drug: Placebo |
| Arm 2 | Experimental | E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for two days and placebo for two days in a 28 day cycle Receives: Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E); Drug: DRSP (ZK 30595) dose 1 (SH T04984F); Drug: Placebo |
| Arm 3 | Experimental | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, and placebo for days 25-28 in a 28 day cycle Receives: Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E); Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739); Drug: E2/DRSP (BAY 86-4891) dose 3 (80458755); Drug: Placebo |
| Arm 4 | Experimental | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 1 (SHT04984F) for one day in a 28 day cycle Receives: Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E); Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739); Drug: E2/DRSP (BAY 86-4891) dose 3 (80458755); Drug: E2/DRSP (BAY 86-4891) dose 4 (80458720); Drug: DRSP (ZK 30595) dose 1 (SH T04984F); Drug: Placebo |
| Arm 5 | Experimental | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891) dose 5 (80458712) for days 17-24, and placebo for 4 days in a 28 day cycle Receives: Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739); Drug: E2/DRSP (BAY 86-4891) dose 5 (80458712); Drug: Placebo |
| Arm 6 | Experimental | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891)dose 5 (80458712) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 2 (80458690) for one day in a 28 day cycle Receives: Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739); Drug: E2/DRSP (BAY 86-4891) dose 4 (80458720); Drug: E2/DRSP (BAY 86-4891) dose 5 (80458712); Drug: DRSP (ZK 30595) dose 2 (80458690); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intracyclic bleeding episodes during cycles 2 to 7
Measured: 168 days
Secondary outcomes (6)
Number of intracyclic bleeding days (including spotting) in Cycles 2 to 7
Measured: 168 days
Number of withdrawal bleeding episodes in Cycles 1 to 6
Measured: 168 days
Bleeding pattern
Bleeding pattern was determined by: - Number of bleeding/spotting days - Number of bleeding days (excluding spotting) - Number of spotting-only days - Number, mean length, maximum length, and range of length of bleeding/spotting episodes - Number, mean length, maximum length, and range of length of spotting-only episodes
Measured: Approximately 7 months
Cycle control
Withdrawal bleeding - Number of volunteers with/without withdrawal bleeding; - Length, maximum intensity, and onset of withdrawal bleeding episodes Intracyclic bleeding (including/excluding spotting) - Number of volunteers with/without intracyclic bleeding; - Number, maximum length, maximum intensity (including spotting only) of intracyclic bleeding episodes - Number of intracyclic bleeding days - Number of volunteers with at least one intracyclic bleeding (including/excluding spotting) episode in Cycles 2 - 6 and in Cycles 2 - 7
Measured: Approximately 7 months
Subjective assessment of treatment
The treatment satisfaction assessment was done through a questionaire. The investigator handed it over to the subject and the subject was asked to answer all questions by herself.
Measured: Day 196 - Day 210
Number of participants with adverse events
Measured: Approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive, Oral, HormonalStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 635 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
- NCT00653614
- Sponsor's protocol ID
- 91765
- Other IDs
- 2007-005258-22, 311926
- Status last verified
- Apr 2015
- First submitted
- 2 Apr 2008
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Parallel-group Study to Evaluate Cycle Control and Safety of 6 Different Regimens of an Oral Contraceptive Containing Estradiol and Drospirenone in Healthy Female Volunteers Aged Between 18 and 35 Years Over 7 Cycles
- ClinicalTrials.gov ID
- NCT00653614
- Acronym / sponsor ID
- 91765
- Conditions
- Contraceptive, Oral, Hormonal
- Keywords
- Oral contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be performed as a multi-center, randomized, double-blind, parallel-group trial in fertile women aged between 18 and 35 years inclusive. A total of 600 volunteers will be randomized into one of the six treatment groups. The study will be performed only in Germany. The investigational drug is an oral contraceptive. It contains the estrogen estradiol (E2) and the progestogen drospirenone (DRSP). As the contraceptive efficacy has not yet been proven for these new regimens, even a protection against unwanted pregnancies cannot be assured. The treatments will be applied daily for 7 cycles of 28 days each without pill-free interval, i.e., for 196 consecutive days. Treatment will be initiated after a screening period of approximately 1 to 2 weeks, the latter focused on confirmation of the baseline safety status. Tablet intake will start on the first day of the first menstrual/withdrawal bleeding after Visit 2, regardless of whether the volunteer is a first user (starter) or switching from another COC. In the following cycles, tablet intake is not to be triggered by any bleeding events. The primary objective of this study is to evaluate and compare the cycle control and bleeding patterns of six different treatment regimens with E2/DRSP during administration for 7 treatment cycles. Volunteers will be provided with a diary to document the intake of study medication, any bleeding events, and days without bleeding, pregnancy test results. Safety will be also assessed. During the whole study period, 4 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breast palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.Additional examinations can be performed any time, if this becomes necessary for medical reasons. At Visit 3 or in case of premature discontinuation of study the investigator will discuss options for follow-up contraception with the volunteer. The volunteer can start the intake of a post-treatment OC on the day after the last tablet intake of study medication, after a negative urine ß-HCG test (home pregnancy test) result.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E), Drug: DRSP (ZK 30595) dose 1 (SH T04984F), Drug: PlaceboE2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for one day and placebo for three days in a 28 day cycle |
| Arm 2 | Experimental | Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E), Drug: DRSP (ZK 30595) dose 1 (SH T04984F), Drug: PlaceboE2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for two days and placebo for two days in a 28 day cycle |
| Arm 3 | Experimental | Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E), Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739), Drug: E2/DRSP (BAY 86-4891) dose 3 (80458755), Drug: PlaceboE2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, and placebo for days 25-28 in a 28 day cycle |
| Arm 4 | Experimental | Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E), Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739), Drug: E2/DRSP (BAY 86-4891) dose 3 (80458755), Drug: E2/DRSP (BAY 86-4891) dose 4 (80458720), Drug: DRSP (ZK 30595) dose 1 (SH T04984F), Drug: PlaceboE2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 1 (SHT04984F) for one day in a 28 day cycle |
| Arm 5 | Experimental | Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739), Drug: E2/DRSP (BAY 86-4891) dose 5 (80458712), Drug: PlaceboE2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891) dose 5 (80458712) for days 17-24, and placebo for 4 days in a 28 day cycle |
| Arm 6 | Experimental | Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739), Drug: E2/DRSP (BAY 86-4891) dose 4 (80458720), Drug: E2/DRSP (BAY 86-4891) dose 5 (80458712), Drug: DRSP (ZK 30595) dose 2 (80458690), Drug: PlaceboE2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891)dose 5 (80458712) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 2 (80458690) for one day in a 28 day cycle |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female volunteers
- Age: 18 - 35 years (inclusive), smokers must not be older than 30 years at inclusion
- History of regular cyclic menstrual periods (with a cycle length between 25 and 35 days)
- Willingness to use barrier methods of contraception (condoms with spermicide, diaphragms with spermicide, spermicidal vaginal suppositories) or abstinence during the trial
Key exclusion criteria (7 listed)
- Pregnancy, lactation (less than three menstrual cycles before Visit 1 following delivery, abortion, or lactation) - Obesity (BMI > 30.0 kg/m2)
- Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at Visit 1 or a normal result has to be documented within the last 6 months before Visit 1)
- Laboratory values outside inclusion range at Screening - Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results, as e.g.: - Cardiovascular -- presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g., transient ischemic attack, angina pectoris) and conditions which could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. -- uncontrolled arterial hypertension (repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
- Liver -- presence or history of liver tumor (benign or malignant) -- presence or history of severe hepatic disease as long as liver function values have not returned to normal -- jaundice and/or pruritus related to cholestasis -- history of cholestatic jaundice associated with pregnancy or previous COC use
- Metabolic diseases -- uncontrolled diabetes mellitus with vascular involvement severe dyslipoproteinemia
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 |
|---|---|---|
| E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)Single dose administration of E2 + DRSP as a tablet | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| E2/DRSP (BAY 86-4891) dose 2 (80458739)Single dose administration of E2 + DRSP as a tablet | Drug | Arm 3, Arm 4, Arm 5, Arm 6 |
| E2/DRSP (BAY 86-4891) dose 3 (80458755)Single dose administration of E2 + DRSP as a tablet | Drug | Arm 3, Arm 4 |
| E2/DRSP (BAY 86-4891) dose 4 (80458720)Single dose administration of E2 + DRSP as a tablet | Drug | Arm 4, Arm 6 |
| E2/DRSP (BAY 86-4891) dose 5 (80458712)Single dose administration of E2 + DRSP as a tablet | Drug | Arm 5, Arm 6 |
| DRSP (ZK 30595) dose 1 (SH T04984F)Single dose administration of DRSP as a tablet | Drug | Arm 1, Arm 2, Arm 4 |
| DRSP (ZK 30595) dose 2 (80458690)Single dose administration of DRSP as a tablet | Drug | Arm 6 |
| PlaceboPlacebo administration in each arm | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
Primary outcome
Number of intracyclic bleeding episodes during cycles 2 to 7
Time frame: 168 days
6 secondary outcomes
Number of intracyclic bleeding days (including spotting) in Cycles 2 to 7
Time frame: 168 days
Number of withdrawal bleeding episodes in Cycles 1 to 6
Time frame: 168 days
Bleeding pattern
Time frame: Approximately 7 months
Cycle control
Time frame: Approximately 7 months
Subjective assessment of treatment
Time frame: Day 196 - Day 210
Number of participants with adverse events
Time frame: Approximately 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- 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
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E2/DRSP (BAY 86-4891) dose 1 (SH T04984E), E2/DRSP (BAY 86-4891) dose 2 (80458739) and E2/DRSP (BAY 86-4891) dose 3 (80458755) in people with Contraceptive, Oral, Hormonal, run by Bayer at 25 sites in Germany.
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 4 inclusion and 7 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of intracyclic bleeding episodes during cycles 2 to 7 (time frame: 168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2015; AzTrials last refreshed its copy on 1 Nov 2026.