NCT05174884

Casea S Contraceptive Implants (Casea S) Trial

A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Removability, Safety, and Tolerability of Casea S Contraceptive Implants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: FHI 360 · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

In Part 1 of this study, four women will each have a single Casea S pellet (22.2 mg ENG) inserted into the inner aspect of the non-dominant upper arm after a negative urine pregnancy test. The insertion site and pellet location will be verified, marked, and photographed. ISRs and AEs will be assessed. In Part 2 of this study, approximately sixteen women will each have two Casea S pellets (44.4 mg ENG) inserted into the inner aspect of the non-dominant upper arm. The insertion site and pellet location will be verified, marked, and photographed. ISRs and AEs will be assessed.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	22.2 mg Etonogestrel (ENG)	Subdermal insertion of a single Casea S pellet (22.2 mg ENG) in healthy female participants
DRUG	44.4 mg Etonogestrel (ENG)	Subdermal insertion of two Casea S pellets (44.4 mg ENG) in healthy female participants

Timeline

• Start date: 2023-12-13
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-01-03
• Last updated: 2026-04-08

Locations

1 site across 1 country: Dominican Republic

Regulatory

• FDA-regulated drug study