A Phase 3 interventional study of Skyla (Levonorgestrel, BAY86-5028) in Contraception, sponsored by Bayer. Completed at 41 sites in 8 countries. Open to female participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-27.
Sponsored by Bayer · Phase 3, Interventional, and Prevention
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.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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