Trial Condition(s):

Contraception

LCS12 vs Combined Oral Contraceptive (COC) user satisfaction study

Bayer Identifier:

13362

ClinicalTrials.gov Identifier:

NCT01254292

EudraCT Number:

2010-020181-21

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
567
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

GENT, Belgium, 9000

Status
Completed
 
Locations

Investigative Site

EKEREN, Belgium, 2180

Status
Completed
 
Locations

Investigative Site

BRUXELLES-BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

Antwerpen, Belgium, 2018

Status
Completed
 
Locations

Investigative Site

St. Pölten, Austria, 3100

Status
Completed
 
Locations

Investigative Site

Zeltweg, Austria, 8740

Status
Completed
 
Locations

Investigative Site

Bregenz, Austria, 6900

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1200

Status
Completed
 
Locations

Investigative Site

Voitsberg, Austria, 8570

Status
Completed
 
Locations

Investigative Site

Tulln, Austria, 3430

Status
Completed
 
Locations

Investigative Site

Klagenfurt, Austria, 9020

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8010

Status
Completed
 
Locations

Investigative Site

Wiener Neustadt, Austria, 2700

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1070

Status
Completed
 
Locations

Investigative Site

Boynton Beach, United States, 33472-2952

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92103

Status
Completed
 
Locations

Investigative Site

Tucson, United States, 85712

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19114

Status
Completed
 
Locations

Investigative Site

La Mesa, United States, 91942

Status
Completed
 
Locations

Investigative Site

Lincoln, United States, 68510

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98105

Status
Completed
 
Locations

Investigative Site

Köln, Germany, 50931

Status
Completed
 
Locations

Investigative Site

Ettlingen, Germany, 76275

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 22587

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02118

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92108

Status
Completed
 
Locations

Investigative Site

Corpus Christi, United States, 78414

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 22159

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30459

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04299

Status
Completed
 
Locations

Investigative Site

Dippoldiswalde, Germany, 01744

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04207

Status
Completed
 
Locations

Investigative Site

Jessen, Germany, 06917

Status
Completed
 
Locations

Investigative Site

Geseke, Germany, 59590

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 199034

Status
Terminated
 
Locations

Investigative Site

Novosibirsk, Russia, 630089

Status
Terminated
 
Locations

Investigative Site

Ivanovo, Russia, 153045

Status
Terminated
 
Locations

Investigative Site

Irkutsk, Russia, 664003

Status
Terminated
 
Locations

Investigative Site

Barnaul, Russia, 656038

Status
Terminated
 
Locations

Investigative Site

Portland, United States, 97239-3011

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43213

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 21073

Status
Completed
 
Locations

Investigative Site

Magdeburg, Germany, 39104

Status
Completed
 
Locations

Investigative Site

Bernburg, Germany, 06406

Status
Completed
 
Locations

Investigative Site

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01169

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

Gynaecologen Noord Antwerpen

EKEREN, Belgium, 2180

Status
Completed
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES-BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Dr. Philip Loquet

Antwerpen, Belgium, 2018

Status
Completed
 
Locations

Ordination Dr. Schmidl-Amann

St. Pölten, Austria, 3100

Status
Completed
 
Locations

Dr. Walter Paulik

Zeltweg, Austria, 8740

Status
Completed
 
Locations

Landeskrankenhaus Bregenz

Bregenz, Austria, 6900

Status
Completed
 
Locations

Dr. Wolfgang Bartl

Wien, Austria, 1200

Status
Completed
 
Locations

Ordination Dr. Trost

Voitsberg, Austria, 8570

Status
Completed
 
Locations

Ordination Dr. Sator

Tulln, Austria, 3430

Status
Completed
 
Locations

Dr. Bernhard Svejda

Klagenfurt, Austria, 9020

Status
Completed
 
Locations

Praxis Dr. Hannes Kahr

Graz, Austria, 8010

Status
Completed
 
Locations

Dr. Max Stiglbauer

Wiener Neustadt, Austria, 2700

Status
Completed
 
Locations

Dr. Brigitte Wiesenthal

Wien, Austria, 1070

Status
Completed
 
Locations

Visions Clinical Research

Boynton Beach, United States, 33472-2952

Status
Completed
 
Locations

Genesis Center for Clinical Research

San Diego, United States, 92103

Status
Completed
 
Locations

Visions Clinical Research - Tucson

Tucson, United States, 85712

Status
Completed
 
Locations

Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

Status
Completed
 
Locations

Grossmont Center for Clinical Research

La Mesa, United States, 91942

Status
Completed
 
Locations

Women's Clinic of Lincoln, PC

Lincoln, United States, 68510

Status
Completed
 
Locations

Seattle Women's: Health, Research, Gynecology

Seattle, United States, 98105

Status
Completed
 
Locations

Evangelisches Krankenhaus Köln Weyertal gGmbH

Köln, Germany, 50931

Status
Completed
 
Locations

Praxis Hr. Dr. A. Soder

Ettlingen, Germany, 76275

Status
Completed
 
Locations

Praxis Hr. Dr. K. Buehling

Hamburg, Germany, 22587

Status
Completed
 
Locations

Boston Medical Center

Boston, United States, 02118

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

Advanced Research Associates

Corpus Christi, United States, 78414

Status
Completed
 
Locations

Praxis Hr. Dr. K. Peters

Hamburg, Germany, 22159

Status
Completed
 
Locations

Praxis Hr. Dr. K. Greven

Hannover, Germany, 30459

Status
Completed
 
Locations

Praxis Fr. C. Burgkhardt

Leipzig, Germany, 04299

Status
Completed
 
Locations

Frauenarztpraxis Dr. Robert Hantschel

Dippoldiswalde, Germany, 01744

Status
Completed
 
Locations

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

Status
Completed
 
Locations

Praxis Hr. H. Thelen

Jessen, Germany, 06917

Status
Completed
 
Locations

Praxis Hr. Dr. E. Goeckeler-Leopold

Geseke, Germany, 59590

Status
Completed
 
Locations

Institute of Obsteric & Gyn.

St. Petersburg, Russia, 199034

Status
Terminated
 
Locations

City Perinatal Center

Novosibirsk, Russia, 630089

Status
Terminated
 
Locations

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

Ivanovo, Russia, 153045

Status
Terminated
 
Locations

Scientific Center of family health & human reprod. problems

Irkutsk, Russia, 664003

Status
Terminated
 
Locations

Altai State Medical University

Barnaul, Russia, 656038

Status
Terminated
 
Locations

Oregon Health and Science University

Portland, United States, 97239-3011

Status
Completed
 
Locations

Columbus Center for Women's Health Research

Columbus, United States, 43213

Status
Completed
 
Locations

Praxis Hr. Dr. D. Rautenberg

Hamburg, Germany, 21073

Status
Completed
 
Locations

Praxis Fr. Dr. A. Braune

Magdeburg, Germany, 39104

Status
Completed
 
Locations

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Germany, 06406

Status
Completed
 
Locations

Frauenarztpraxis Dr. Wetzel

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Praxis Hr. Dr. U. Kopprasch

Dresden, Germany, 01169

Status
Completed
 

Trial Design