LCS12 Adolescent Study
The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. Approximately 300 generally healthy, post-menarcheal female adolescents with regular menses at the beginning of the study requiring contraception will be enrolled into the study.
Duration of study treatment is approximately 12 months with an option to continue the use of the contraceptive system up to three years if the woman is willing to continue the use after the first 12 months.
The incidence of adverse events over 12 month treatment period will be the main outcome of this study. Also the efficacy (number of pregnancies), discontinuation rate and pharmacokinetics will be evaluated.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Multi-center, Single-arm Study to Assess the Safety, Efficacy, Discontinuation Rate and Pharmacokinetics of the Low-dose Levonorgestrel Intrauterine Contraceptive System (LCS12) in Post-menarcheal Female Adolescents Under 18 Years of Age for 1 Year, and an Optional 2-year Extension Phase|
- Number of adverse events reported by study subjects [ Time Frame: 12 months treatment period ]
- Portion of subjects reporting adverse events [ Time Frame: 12 months treatment period ]
- Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied) [ Time Frame: 12 months treatment period ]
- Pearl index [ Time Frame: 12 months treatment period ]
- Bleeding patterns collected from patients' diary [ Time Frame: 12 months treatment period ]
- Concentration of Levonorgestrel in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ]
- Concentration of sex hormone binding globulin in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ]
- Discontinuation rate [ Time Frame: 12 months treatment period ]
|Study Start Date:||September 2011|
|Study Completion Date:||May 2015|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Drug: Skyla (Levonorgestrel, BAY86-5028)
Levonorgestrel intrauterine contraceptive system (LCS12) insertion into the uterus at insertion visit 2 with the study treatment of 12 months. An optional follow up phase up to 3 years will be offered for all subjects completing 12 month treatment time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434160
Show 41 Study Locations
|Study Director:||Bayer Study Director||Bayer|