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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
304
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.
Unnamed facility
Sankt Pölten, Lower Austria, Austria
Unnamed facility
Bregenz, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Voitsberg, Austria
Unnamed facility
Zeltweg, Austria
Unnamed facility
Antwerp, Belgium
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Charleroi, Belgium
Unnamed facility
Leuven, Belgium
...and 31 more locations
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
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