LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

NCT01254292 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 133622010-020181-21
• Study Type: interventional
• Target: 567
• Locations: 5 countries
• Sites: 94

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

Outcome Measures

Primary Outcomes (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.

  At 18 months

Secondary Outcomes (25)

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

  At 6 months

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

  At 12 months

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

  At 18 months

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

  At 18 months/EOS

• Overall Satisfaction Rate at 6 Months (LOCF)

  At 6 months

Other Outcomes (5)

• Cumulative Number of Participants With Partial or Total Expulsion

  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

Study Arms (2)

LCS12 (Skyla, BAY86-5028)

EXPERIMENTAL

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)

EE30/DRSP (Yasmin, BAY86-5131)

ACTIVE COMPARATOR

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)

Interventions

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.

LCS12 (Skyla, BAY86-5028)

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.

EE30/DRSP (Yasmin, BAY86-5131)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (94)

Visions Clinical Research - Tucson

Tucson, Arizona, 85712, United States

Location

Unknown Facility

Tucson, Arizona, 85712, United States

Location

Grossmont Center for Clinical Research

La Mesa, California, 91942, United States

Location

Unknown Facility

La Mesa, California, 91942, United States

Location

Genesis Center for Clinical Research

San Diego, California, 92103, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472-2952, United States

Location

Unknown Facility

Boynton Beach, Florida, 33472-2952, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Unknown Facility

Boston, Massachusetts, 02118, United States

Location

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, 68510, United States

Location

Unknown Facility

Lincoln, Nebraska, 68510, United States

Location

Columbus Center for Women's Health Research

Columbus, Ohio, 43213, United States

Location

Unknown Facility

Columbus, Ohio, 43213, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3011, United States

Location

Unknown Facility

Portland, Oregon, 97239-3011, United States

Location

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19114, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

Unknown Facility

Corpus Christi, Texas, 78414, United States

Location

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

Unknown Facility

Seattle, Washington, 98105, United States

Location

Ordination Dr. Schmidl-Amann

Sankt Pölten, Lower Austria, 3100, Austria

Location

Unknown Facility

Sankt Pölten, Lower Austria, 3100, Austria

Location

Dr. Max Stiglbauer

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Unknown Facility

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Ordination Dr. Trost

Voitsberg, Styria, 8570, Austria

Location

Unknown Facility

Voitsberg, Styria, 8570, Austria

Location

Landeskrankenhaus Bregenz

Bregenz, Vorarlberg, 6900, Austria

Location

Unknown Facility

Bregenz, Vorarlberg, 6900, Austria

Location

Praxis Dr. Hannes Kahr

Graz, 8010, Austria

Location

Unknown Facility

Graz, 8010, Austria

Location

Dr. Bernhard Svejda

Klagenfurt, 9020, Austria

Location

Unknown Facility

Klagenfurt, 9020, Austria

Location

Ordination Dr. Sator

Tulln, 3430, Austria

Location

Unknown Facility

Tulln, 3430, Austria

Location

Dr. Brigitte Wiesenthal

Vienna, 1070, Austria

Location

Unknown Facility

Vienna, 1070, Austria

Location

Dr. Wolfgang Bartl

Vienna, 1200, Austria

Location

Unknown Facility

Vienna, 1200, Austria

Location

Dr. Walter Paulik

Zeltweg, 8740, Austria

Location

Unknown Facility

Zeltweg, 8740, Austria

Location

Dr. Philip Loquet

Antwerp, 2018, Belgium

Location

Unknown Facility

Antwerp, 2018, Belgium

Location

Hôpital Erasme/Erasmus Ziekenhuis

Bruxelles-brussel, 1070, Belgium

Location

Unknown Facility

Bruxelles-brussel, 1070, Belgium

Location

Gynaecologen Noord Antwerpen

Ekeren, 2180, Belgium

Location

Unknown Facility

Ekeren, 2180, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Unknown Facility

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Praxis Hr. Dr. A. Soder

Ettlingen, Baden-Wurttemberg, 76275, Germany

Location

Unknown Facility

Ettlingen, Baden-Wurttemberg, 76275, Germany

Location

Praxis Hr. Dr. K. Greven

Hanover, Lower Saxony, 30459, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30459, Germany

Location

Evangelisches Krankenhaus Köln Weyertal gGmbH

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Unknown Facility

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Praxis Hr. Dr. E. Goeckeler-Leopold

Geseke, North Rhine-Westphalia, 59590, Germany

Location

Unknown Facility

Geseke, North Rhine-Westphalia, 59590, Germany

Location

Frauenarztpraxis Dr. Robert Hantschel

Dippoldiswalde, Saxony, 01744, Germany

Location

Unknown Facility

Dippoldiswalde, Saxony, 01744, Germany

Location

Praxis Hr. Dr. U. Kopprasch

Dresden, Saxony, 01169, Germany

Location

Unknown Facility

Dresden, Saxony, 01169, Germany

Location

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Saxony, 04207, Germany

Location

Unknown Facility

Leipzig, Saxony, 04207, Germany

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Praxis Fr. C. Burgkhardt

Leipzig, Saxony, 04299, Germany

Location

Unknown Facility

Leipzig, Saxony, 04299, Germany

Location

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Saxony-Anhalt, 06406, Germany

Location

Unknown Facility

Bernburg, Saxony-Anhalt, 06406, Germany

Location

Frauenarztpraxis Dr. Wetzel

Blankenburg, Saxony-Anhalt, 38889, Germany

Location

Unknown Facility

Blankenburg, Saxony-Anhalt, 38889, Germany

Location

Praxis Hr. H. Thelen

Jessen, Saxony-Anhalt, 06917, Germany

Location

Unknown Facility

Jessen, Saxony-Anhalt, 06917, Germany

Location

Praxis Fr. Dr. A. Braune

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Praxis Hr. Dr. D. Rautenberg

Hamburg, 21073, Germany

Location

Unknown Facility

Hamburg, 21073, Germany

Location

Praxis Hr. Dr. K. Peters

Hamburg, 22159, Germany

Location

Unknown Facility

Hamburg, 22159, Germany

Location

Praxis Hr. Dr. K. Buehling

Hamburg, 22587, Germany

Location

Unknown Facility

Hamburg, 22587, Germany

Location

Altai State Medical University

Barnaul, 656038, Russia

Location

Unknown Facility

Barnaul, 656038, Russia

Location

Scientific Center of family health & human reprod. problems

Irkutsk, 664003, Russia

Location

Unknown Facility

Irkutsk, 664003, Russia

Location

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

Ivanovo, 153045, Russia

Location

Unknown Facility

Ivanovo, 153045, Russia

Location

City Perinatal Center

Novosibirsk, 630089, Russia

Location

Unknown Facility

Novosibirsk, 630089, Russia

Location

Institute of Obsteric & Gyn.

Saint Petersburg, 199034, Russia

Location

Unknown Facility

Saint Petersburg, 199034, Russia

Location

Related Links

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

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: December 6, 2010
• Study Start: January 6, 2011
• Primary Completion: January 8, 2013
• Study Completion: May 28, 2014
• Last Updated: September 25, 2017
• Results First Posted: April 7, 2014

Record last verified: 2017-08

Locations

RU (10); AU (20); BE (10); DE (30); US (24)