LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

NCT ID: NCT01254292

Last Updated: 2017-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 567 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-06
• Study Completion Date: 2014-05-28

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Levonorgestrel IUD (LCS, BAY86-5028)

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Yasmin (EE30/DRSP, BAY86-5131)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• 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.

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Visions Clinical Research - Tucson

Tucson, Arizona, United States

Tucson, Arizona, United States

Grossmont Center for Clinical Research

La Mesa, California, United States

La Mesa, California, United States

Genesis Center for Clinical Research

San Diego, California, United States

San Diego, California, United States

Medical Center for Clinical Research

San Diego, California, United States

San Diego, California, United States

Visions Clinical Research

Boynton Beach, Florida, United States

Boynton Beach, Florida, United States

Boston Medical Center

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, United States

Lincoln, Nebraska, United States

Columbus Center for Women's Health Research

Columbus, Ohio, United States

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Portland, Oregon, United States

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Advanced Research Associates

Corpus Christi, Texas, United States

Corpus Christi, Texas, United States

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, United States

Seattle, Washington, United States

Ordination Dr. Schmidl-Amann

Sankt Pölten, Lower Austria, Austria

Sankt Pölten, Lower Austria, Austria

Dr. Max Stiglbauer

Wiener Neustadt, Lower Austria, Austria

Wiener Neustadt, Lower Austria, Austria

Ordination Dr. Trost

Voitsberg, Styria, Austria

Voitsberg, Styria, Austria

Landeskrankenhaus Bregenz

Bregenz, Vorarlberg, Austria

Bregenz, Vorarlberg, Austria

Praxis Dr. Hannes Kahr

Graz, , Austria

Graz, , Austria

Dr. Bernhard Svejda

Klagenfurt, , Austria

Klagenfurt, , Austria

Ordination Dr. Sator

Tulln, , Austria

Tulln, , Austria

Dr. Brigitte Wiesenthal

Vienna, , Austria

Vienna, , Austria

Dr. Wolfgang Bartl

Vienna, , Austria

Vienna, , Austria

Dr. Walter Paulik

Zeltweg, , Austria

Zeltweg, , Austria

Dr. Philip Loquet

Antwerp, , Belgium

Antwerp, , Belgium

Hôpital Erasme/Erasmus Ziekenhuis

Bruxelles-brussel, , Belgium

Bruxelles-brussel, , Belgium

Gynaecologen Noord Antwerpen

Ekeren, , Belgium

Ekeren, , Belgium

UZ Gent

Ghent, , Belgium

Ghent, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

Leuven, , Belgium

Praxis Hr. Dr. A. Soder

Ettlingen, Baden-Wurttemberg, Germany

Ettlingen, Baden-Wurttemberg, Germany

Praxis Hr. Dr. K. Greven

Hanover, Lower Saxony, Germany

Hanover, Lower Saxony, Germany

Evangelisches Krankenhaus Köln Weyertal gGmbH

Cologne, North Rhine-Westphalia, Germany

Cologne, North Rhine-Westphalia, Germany

Praxis Hr. Dr. E. Goeckeler-Leopold

Geseke, North Rhine-Westphalia, Germany

Geseke, North Rhine-Westphalia, Germany

Frauenarztpraxis Dr. Robert Hantschel

Dippoldiswalde, Saxony, Germany

Dippoldiswalde, Saxony, Germany

Praxis Hr. Dr. U. Kopprasch

Dresden, Saxony, Germany

Dresden, Saxony, Germany

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Saxony, Germany

Leipzig, Saxony, Germany

Praxis Fr. C. Burgkhardt

Leipzig, Saxony, Germany

Leipzig, Saxony, Germany

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Saxony-Anhalt, Germany

Bernburg, Saxony-Anhalt, Germany

Frauenarztpraxis Dr. Wetzel

Blankenburg, Saxony-Anhalt, Germany

Blankenburg, Saxony-Anhalt, Germany

Praxis Hr. H. Thelen

Jessen, Saxony-Anhalt, Germany

Jessen, Saxony-Anhalt, Germany

Praxis Fr. Dr. A. Braune

Magdeburg, Saxony-Anhalt, Germany

Magdeburg, Saxony-Anhalt, Germany

Praxis Hr. Dr. D. Rautenberg

Hamburg, , Germany

Hamburg, , Germany

Praxis Hr. Dr. K. Peters

Hamburg, , Germany

Hamburg, , Germany

Praxis Hr. Dr. K. Buehling

Hamburg, , Germany

Hamburg, , Germany

Altai State Medical University

Barnaul, , Russia

Barnaul, , Russia

Scientific Center of family health & human reprod. problems

Irkutsk, , Russia

Irkutsk, , Russia

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

Ivanovo, , Russia

Ivanovo, , Russia

City Perinatal Center

Novosibirsk, , Russia

Novosibirsk, , Russia

Institute of Obsteric & Gyn.

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Countries

United States; Austria; Belgium; Germany; Russia

Related Links

http://www.clinicaltrialsregister.eu/

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

Other Identifiers

2010-020181-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13362

Identifier Type: -

Identifier Source: org_study_id