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ACTIVE NOT RECRUITING
NCT05174884
PHASE1

Casea S Contraceptive Implants (Casea S) Trial

Sponsor: FHI 360

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-12-13

Completion Date

2027-06

Last Updated

2026-04-08

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

Clinica Profamilia

Santo Domingo, DN, Dominican Republic