LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

Completed · Phase 3

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT01254292

Run by

Bayer

People needed

567

Starts

2011-01-06

Expected to finish

2014-05-28

Last updated by the study team

2017-09-25

Who can join

Age: 18 and older, up to 29. Sex: female. Healthy volunteers: not accepted.

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)
• 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.

Where it is running

• Study site — Tucson, Arizona, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• Study site — La Mesa, California, United States
• Genesis Center for Clinical Research — San Diego, California, United States
• Study site — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Study site — San Diego, California, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Study site — Boynton Beach, Florida, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Women's Clinic of Lincoln, PC — Lincoln, Nebraska, United States
• Study site — Lincoln, Nebraska, United States
• Columbus Center for Women's Health Research — Columbus, Ohio, United States
• Study site — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Study site — Portland, Oregon, United States
• Clinical Research of Philadelphia, LLC — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Advanced Research Associates — Corpus Christi, Texas, United States
• Study site — Corpus Christi, Texas, United States
• Seattle Women's: Health, Research, Gynecology — Seattle, Washington, United States
• Study site — Seattle, Washington, United States
• Ordination Dr. Schmidl-Amann — Sankt Pölten, Lower Austria, Austria
• Visions Clinical Research - Tucson — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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