LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Levonorgestrel IUD (LCS, BAY86-5028); Drug: Yasmin (EE30/DRSP, BAY86-5131)

• Study Type: Interventional
• Enrollment (Actual): 567
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
  • Graz, Austria, 8010
    • Praxis Dr. Hannes Kahr
  • Klagenfurt, Austria, 9020
    • Dr. Bernhard Svejda
  • Klagenfurt, Austria, 9020
  • Tulln, Austria, 3430
    • Ordination Dr. Sator
  • Tulln, Austria, 3430
  • Wien, Austria, 1070
  • Wien, Austria, 1200
  • Wien, Austria, 1070
    • Dr. Brigitte Wiesenthal
  • Wien, Austria, 1200
    • Dr. Wolfgang Bartl
  • Zeltweg, Austria, 8740
  • Zeltweg, Austria, 8740
    • Dr. Walter Paulik
  • Niederösterreich
    • St. Pölten, Niederösterreich, Austria, 3100
    • St. Pölten, Niederösterreich, Austria, 3100
      • Ordination Dr. Schmidl-Amann
    • Wiener Neustadt, Niederösterreich, Austria, 2700
    • Wiener Neustadt, Niederösterreich, Austria, 2700
      • Dr. Max Stiglbauer
  • Steiermark
    • Voitsberg, Steiermark, Austria, 8570
      • Ordination Dr. Trost
    • Voitsberg, Steiermark, Austria, 8570
  • Vorarlberg
    • Bregenz, Vorarlberg, Austria, 6900
    • Bregenz, Vorarlberg, Austria, 6900
      • Landeskrankenhaus Bregenz
• Belgium
  • Antwerpen, Belgium, 2018
  • Antwerpen, Belgium, 2018
    • Dr. Philip Loquet
  • Bruxelles-brussel, Belgium, 1070
    • Hôpital Erasme/Erasmus Ziekenhuis
  • Bruxelles-brussel, Belgium, 1070
  • Ekeren, Belgium, 2180
  • Ekeren, Belgium, 2180
    • Gynaecologen Noord Antwerpen
  • Gent, Belgium, 9000
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Germany
  • Hamburg, Germany, 22159
  • Hamburg, Germany, 22159
    • Praxis Hr. Dr. K. Peters
  • Hamburg, Germany, 21073
  • Hamburg, Germany, 22587
  • Hamburg, Germany, 21073
    • Praxis Hr. Dr. D. Rautenberg
  • Hamburg, Germany, 22587
    • Praxis Hr. Dr. K. Buehling
  • Baden-Württemberg
    • Ettlingen, Baden-Württemberg, Germany, 76275
      • Praxis Hr. Dr. A. Soder
    • Ettlingen, Baden-Württemberg, Germany, 76275
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30459
    • Hannover, Niedersachsen, Germany, 30459
      • Praxis Hr. Dr. K. Greven
  • Nordrhein-Westfalen
    • Geseke, Nordrhein-Westfalen, Germany, 59590
    • Geseke, Nordrhein-Westfalen, Germany, 59590
      • Praxis Hr. Dr. E. Goeckeler-Leopold
    • Köln, Nordrhein-Westfalen, Germany, 50931
    • Köln, Nordrhein-Westfalen, Germany, 50931
      • Evangelisches Krankenhaus Köln Weyertal gGmbH
  • Sachsen
    • Dippoldiswalde, Sachsen, Germany, 01744
    • Dippoldiswalde, Sachsen, Germany, 01744
      • Frauenarztpraxis Dr. Robert Hantschel
    • Dresden, Sachsen, Germany, 01169
    • Dresden, Sachsen, Germany, 01169
      • Praxis Hr. Dr. U. Kopprasch
    • Leipzig, Sachsen, Germany, 04207
    • Leipzig, Sachsen, Germany, 04299
    • Leipzig, Sachsen, Germany, 04207
      • Frauenarztpraxis Dr. Bernd Pittner
    • Leipzig, Sachsen, Germany, 04299
      • Praxis Fr. C. Burgkhardt
  • Sachsen-Anhalt
    • Bernburg, Sachsen-Anhalt, Germany, 06406
      • Praxis f. Gynäkologie und Geburtshilfe
    • Bernburg, Sachsen-Anhalt, Germany, 06406
    • Blankenburg, Sachsen-Anhalt, Germany, 38889
    • Blankenburg, Sachsen-Anhalt, Germany, 38889
      • Frauenarztpraxis Dr. Wetzel
    • Jessen, Sachsen-Anhalt, Germany, 06917
    • Jessen, Sachsen-Anhalt, Germany, 06917
      • Praxis Hr. H. Thelen
    • Magdeburg, Sachsen-Anhalt, Germany, 39104
    • Magdeburg, Sachsen-Anhalt, Germany, 39104
      • Praxis Fr. Dr. A. Braune
• Russian Federation
  • Barnaul, Russian Federation, 656038
  • Barnaul, Russian Federation, 656038
    • Altai State Medical University
  • Irkutsk, Russian Federation, 664003
    • Scientific Center of family health & human reprod. problems
  • Irkutsk, Russian Federation, 664003
  • Ivanovo, Russian Federation, 153045
  • Ivanovo, Russian Federation, 153045
    • Instit. of Motherhood & Childhood care n.a. Gorodkov
  • Novosibirsk, Russian Federation, 630089
  • Novosibirsk, Russian Federation, 630089
    • City Perinatal Center
  • St. Petersburg, Russian Federation, 199034
  • St. Petersburg, Russian Federation, 199034
    • Institute of Obsteric & Gyn.
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research - Tucson
  • California
    • La Mesa, California, United States, 91942
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • San Diego, California, United States, 92103
    • San Diego, California, United States, 92108
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92103
      • Genesis Center for Clinical Research
  • Florida
    • Boynton Beach, Florida, United States, 33472-2952
    • Boynton Beach, Florida, United States, 33472-2952
      • Visions Clinical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02118
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC
    • Lincoln, Nebraska, United States, 68510
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Columbus Center for Women's Health Research
    • Columbus, Ohio, United States, 43213
  • Oregon
    • Portland, Oregon, United States, 97239-3011
    • Portland, Oregon, United States, 97239-3011
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia, LLC
    • Philadelphia, Pennsylvania, United States, 19114
  • Texas
    • Corpus Christi, Texas, United States, 78414
    • Corpus Christi, Texas, United States, 78414
      • Advanced Research Associates
  • Washington
    • Seattle, Washington, United States, 98105
    • Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research, Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LCS12 (Skyla, BAY86-5028); Participants 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	Drug: Levonorgestrel IUD (LCS, BAY86-5028); 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.
Active Comparator: EE30/DRSP (Yasmin, BAY86-5131); Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles	Drug: Yasmin (EE30/DRSP, BAY86-5131); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 6 months
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.	At 12 months
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.	At 18 months
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.	At 18 months/EOS
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.	At 6 months
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.	At 12 months
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.	At 18 months/EOS
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.	At 18 months/EOS
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.	At 18 months/EOS
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.	At 18 months/EOS
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.	At 18 months/EOS
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.	At 18 months/EOS
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.	At 18 months/EOS
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.	At 18 months/EOS
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.	At screening
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.	At screening
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.	At 6 months
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.	At 12 months
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.	At 12 months
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.	At 18 months/EOS
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.	Up to 6, 12, 18, 24 and 36 months
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.	Up to 18, 24, 36 months
Compliance Rate for Yasmin Pill Intake		Up to 18 months
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.	At 6 months
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.	At 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Number of Participants With Partial or Total Expulsion	Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.	Up to 18, 24, 36 months
Investigator's Evaluation of Successful IUS Insertion Procedure		Up to 18 months
Participants' Evaluation of Pain During Successful IUS Insertion Procedure		Up to 18 months
Investigator's Evaluation of IUS Removal Procedure		Up to 36 months
Participants' Evaluation of Pain During IUS Removal Procedure		Up to 36 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2011
• Primary Completion (Actual): January 8, 2013
• Study Completion (Actual): May 28, 2014

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (Estimate): December 6, 2010

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 13362; 2010-020181-21 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No