AzTrials
AzTrials

ContraceptionPhase 3NCT01254292

LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

A Phase 3 study testing Levonorgestrel IUD (LCS, BAY86-5028) and Yasmin (EE30/DRSP, BAY86-5131) in people with Contraception, run by Bayer at 94 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Read more about this study

Who is it for?
Ages 18 to 29 years, women only
Conditions the study is for
Contraception
What is being tested?
Levonorgestrel IUD (LCS, BAY86-5028) and Yasmin (EE30/DRSP, BAY86-5131)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
567 participants
Where
94 sitesin 5 countries
Study dates
6 Jan 2011to 28 May 2014
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 29 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject has signed and dated the Informed Consent Form (ICF).
  • The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.
  • In the opinion of the investigator, the subject is
  • in good health;
  • without uterine conditions that would preempt insertion of LCS12;
  • without conditions/history that would contraindicate the use of oral contraceptives.
Show all 9Show fewer
  • Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.
  • As determined by subject's history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).
  • Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Who cannot join

  • Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.
  • Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1)
  • Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.
  • Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding
  • Any genital infection (until successfully treated)
  • Abnormal cervical smear result (see inclusion criteria)
  • Acute, current or history of recurrent pelvic inflammatory disease
  • Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.

Trial locations and contacts

94 sites in 5 countries.

94 sites in 5 countries

Germany30 sites

  • Praxis f. Gynäkologie und Geburtshilfe

    Bernburg, Saxony-Anhalt, 06406

  • Study site

    Bernburg, Saxony-Anhalt, 06406

  • Frauenarztpraxis Dr. Wetzel

    Blankenburg, Saxony-Anhalt, 38889

  • Study site

    Blankenburg, Saxony-Anhalt, 38889

  • Evangelisches Krankenhaus Köln Weyertal gGmbH

    Cologne, North Rhine-Westphalia, 50931

  • Study site

    Cologne, North Rhine-Westphalia, 50931

  • Frauenarztpraxis Dr. Robert Hantschel

    Dippoldiswalde, Saxony, 01744

  • Study site

    Dippoldiswalde, Saxony, 01744

  • Praxis Hr. Dr. U. Kopprasch

    Dresden, Saxony, 01169

  • Study site

    Dresden, Saxony, 01169

  • Praxis Hr. Dr. A. Soder

    Ettlingen, Baden-Wurttemberg, 76275

  • Study site

    Ettlingen, Baden-Wurttemberg, 76275

  • Praxis Hr. Dr. E. Goeckeler-Leopold

    Geseke, North Rhine-Westphalia, 59590

  • Study site

    Geseke, North Rhine-Westphalia, 59590

  • Praxis Hr. Dr. D. Rautenberg

    Hamburg, 21073

  • Study site

    Hamburg, 21073

  • Praxis Hr. Dr. K. Peters

    Hamburg, 22159

  • Study site

    Hamburg, 22159

  • Praxis Hr. Dr. K. Buehling

    Hamburg, 22587

  • Study site

    Hamburg, 22587

  • Praxis Hr. Dr. K. Greven

    Hanover, Lower Saxony, 30459

  • Study site

    Hanover, Lower Saxony, 30459

  • Praxis Hr. H. Thelen

    Jessen, Saxony-Anhalt, 06917

  • Study site

    Jessen, Saxony-Anhalt, 06917

  • Frauenarztpraxis Dr. Bernd Pittner

    Leipzig, Saxony, 04207

  • Study site

    Leipzig, Saxony, 04207

  • Praxis Fr. C. Burgkhardt

    Leipzig, Saxony, 04299

  • Study site

    Leipzig, Saxony, 04299

  • Praxis Fr. Dr. A. Braune

    Magdeburg, Saxony-Anhalt, 39104

  • Study site

    Magdeburg, Saxony-Anhalt, 39104

Other trials in Germany

United States24 sites

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Study site

    Boston, Massachusetts, 02118

  • Visions Clinical Research

    Boynton Beach, Florida, 33472-2952

  • Study site

    Boynton Beach, Florida, 33472-2952

  • Columbus Center for Women's Health Research

    Columbus, Ohio, 43213

  • Study site

    Columbus, Ohio, 43213

  • Advanced Research Associates

    Corpus Christi, Texas, 78414

  • Study site

    Corpus Christi, Texas, 78414

  • Grossmont Center for Clinical Research

    La Mesa, California, 91942

  • Study site

    La Mesa, California, 91942

  • Women's Clinic of Lincoln, PC

    Lincoln, Nebraska, 68510

  • Study site

    Lincoln, Nebraska, 68510

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Oregon Health and Science University

    Portland, Oregon, 97239-3011

  • Study site

    Portland, Oregon, 97239-3011

  • Genesis Center for Clinical Research

    San Diego, California, 92103

  • Study site

    San Diego, California, 92103

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Study site

    San Diego, California, 92108

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington, 98105

  • Study site

    Seattle, Washington, 98105

  • Visions Clinical Research - Tucson

    Tucson, Arizona, 85712

  • Study site

    Tucson, Arizona, 85712

Other trials in United States

Austria20 sites

  • Landeskrankenhaus Bregenz

    Bregenz, Vorarlberg, 6900

  • Study site

    Bregenz, Vorarlberg, 6900

  • Praxis Dr. Hannes Kahr

    Graz, 8010

  • Study site

    Graz, 8010

  • Dr. Bernhard Svejda

    Klagenfurt, 9020

  • Study site

    Klagenfurt, 9020

  • Ordination Dr. Schmidl-Amann

    Sankt Pölten, Lower Austria, 3100

  • Study site

    Sankt Pölten, Lower Austria, 3100

  • Ordination Dr. Sator

    Tulln, 3430

  • Study site

    Tulln, 3430

  • Dr. Brigitte Wiesenthal

    Vienna, 1070

  • Study site

    Vienna, 1070

  • Dr. Wolfgang Bartl

    Vienna, 1200

  • Study site

    Vienna, 1200

  • Ordination Dr. Trost

    Voitsberg, Styria, 8570

  • Study site

    Voitsberg, Styria, 8570

  • Dr. Max Stiglbauer

    Wiener Neustadt, Lower Austria, 2700

  • Study site

    Wiener Neustadt, Lower Austria, 2700

  • Dr. Walter Paulik

    Zeltweg, 8740

  • Study site

    Zeltweg, 8740

Other trials in Austria

Belgium10 sites

  • Dr. Philip Loquet

    Antwerp, 2018

  • Study site

    Antwerp, 2018

  • Hôpital Erasme/Erasmus Ziekenhuis

    Bruxelles-brussel, 1070

  • Study site

    Bruxelles-brussel, 1070

  • Gynaecologen Noord Antwerpen

    Ekeren, 2180

  • Study site

    Ekeren, 2180

  • UZ Gent

    Ghent, 9000

  • Study site

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Study site

    Leuven, 3000

Other trials in Belgium

Russia10 sites

  • Altai State Medical University

    Barnaul, 656038

  • Study site

    Barnaul, 656038

  • Scientific Center of family health & human reprod. problems

    Irkutsk, 664003

  • Study site

    Irkutsk, 664003

  • Instit. of Motherhood & Childhood care n.a. Gorodkov

    Ivanovo, 153045

  • Study site

    Ivanovo, 153045

  • City Perinatal Center

    Novosibirsk, 630089

  • Study site

    Novosibirsk, 630089

  • Institute of Obsteric & Gyn.

    Saint Petersburg, 199034

  • Study site

    Saint Petersburg, 199034

Other trials in Russia

About this study

Official title: Multicenter, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 12 µg LNG/Day Initial in Vitro Release Rate (LCS12) in Comparison to a Combined Oral Contraceptive Containing 30 µg Ethinyl Estradiol and 3 mg Drospirenone (Yasmin®) in Young Women (18-29 Years) Over 18 Months of Use

The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study.

Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.

Conditions
Contraception
Being tested
Levonorgestrel IUD (LCS, BAY86-5028), Yasmin (EE30/DRSP, BAY86-5131)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levonorgestrel IUD (LCS, BAY86-5028)Drug

    LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.

  • Yasmin (EE30/DRSP, BAY86-5131)Drug

    Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.

Study groups in NCT01254292
Study groupRoleWhat they receive
LCS12 (Skyla, BAY86-5028)ExperimentalParticipants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Receives: Drug: Levonorgestrel IUD (LCS, BAY86-5028)
EE30/DRSP (Yasmin, BAY86-5131)Active comparatorParticipants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Receives: Drug: Yasmin (EE30/DRSP, BAY86-5131)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)

    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

    Measured: At 18 months

Secondary outcomes (25)

  1. Overall Satisfaction Rating by the 5-point Likert Item at 6 Months

    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

    Measured: At 6 months

  2. Overall Satisfaction Rating by the 5-point Likert Item at 12 Months

    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

    Measured: At 12 months

  3. Overall Satisfaction Rating by the 5-point Likert Item at 18 Months

    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

    Measured: At 18 months

  4. Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)

    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  5. Overall Satisfaction Rate at 6 Months (LOCF)

    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

    Measured: At 6 months

  6. Overall Satisfaction Rate at 12 Months (LOCF)

    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

    Measured: At 12 months

  7. User Satisfaction - Acceptability of the Administration of Study Treatment

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  8. User Satisfaction - Choices Upon Completion of the Study

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  9. User Satisfaction - Amount of Menstrual Bleeding

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  10. User Satisfaction - Satisfaction With Menstrual Bleeding Pattern

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  11. User Satisfaction - Frequency of Experiencing Unexpected Bleeding

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  12. User Satisfaction - Satisfaction With Menstrual Bleeding Absence

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  13. User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  14. User Satisfaction - Rating of Usual Menstrual Pain Intensity

    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  15. EVAPIL-R Scores at Screening - Composite Score

    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

    Measured: At screening

  16. EVAPIL-R Scores at Screening - Bother Score

    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.

    Measured: At screening

  17. EVAPIL-R Scores at 6 Months

    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

    Measured: At 6 months

  18. EVAPIL-R Scores at 12 Months - Bother Score

    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

    Measured: At 12 months

  19. EVAPIL-R Scores at 12 Months - Composite Score

    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

    Measured: At 12 months

  20. EVAPIL-R Scores at 18 Months/EOS

    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.

    Measured: At 18 months/EOS

  21. Cumulative Drop-out Rate

    The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.

    Measured: Up to 6, 12, 18, 24 and 36 months

  22. Pearl Index (PI)

    The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.

    Measured: Up to 18, 24, 36 months

  23. Compliance Rate for Yasmin Pill Intake

    Measured: Up to 18 months

  24. User Satisfaction - Acceptability of the Administration of Study Treatment

    The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.

    Measured: At 6 months

  25. User Satisfaction - Acceptability of the Administration of Study Treatment

    The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.

    Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2010 (estimated)
  2. Study start6 Jan 2011
  3. Primary completion8 Jan 2013
  4. Study completion28 May 2014

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01254292
Sponsor's protocol ID
13362
Other IDs
2010-020181-21
Status last verified
Aug 2017
First submitted
22 Nov 2010
Last updated
25 Sep 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levonorgestrel IUD (LCS, BAY86-5028) and Yasmin (EE30/DRSP, BAY86-5131) in people with Contraception, run by Bayer at 94 sites in 5 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 9 inclusion and 8 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Germany, United States, Austria, Belgium, Russia. 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 7 Apr 2014). 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?

Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF) (time frame: At 18 months). 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 NCT01254292.

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 25 Sep 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in