Contraception Clinical Trial
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
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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