This is a single-center, two-part, Phase 1 study to evaluate the pharmacokinetics (PK) of ENG, removability, safety, and tolerability of Casea S pellets inserted subdermally in healthy women of reproductive age. The goal is to select for further investigation a dose of Casea S that is both safe and has a PK profile consistent with contraceptive protection for at least 78 weeks.
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Maximum observed serum concentration (Cmax)
Timeframe: 12 weeks; 52 weeks; 114 weeks
Time to Cmax (tmax)
Timeframe: 12 weeks; 52 weeks; 114 weeks
Geometric mean serum ENG concentration
Timeframe: 28 days; 84 days; 114 weeks
Area under concentration time curve (AUC 0-28)
Timeframe: 28 days; 84 days; 154 days; 364 days
Predicted concentration at day 546 and probability of exceeding 90 pg/mL through day 546
Timeframe: 52 weeks
Assessment of the removability of Casea S pellets
Timeframe: up to 26 weeks
Assessment Casea S pellets removability
Timeframe: up to 26 weeks
Ability to completely remove the pellet and ease of removal
Timeframe: up to 26 weeks
Time to undetectable ENG levels
Timeframe: 114 weeks