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Casea S Contraceptive Implants (Casea S) Trial

NCT05174884 ↗

Phase 1 Active not recruiting 20 enrolled FHI 360 Bill and Melinda Gates Foundation · collab
Non-randomizedSingle-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2023-12-13
Primary completion
2027-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Etonogestrel Unknown 22.2 mg Other
Subject Etonogestrel Unknown 44.4 mg Other

Indications

No indication recorded.