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Casea S Contraceptive Implants (Casea S) Trial

NCT05174884 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Contraception

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

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • FHI 360

    lead OTHER

Principal Investigators

  • Kavita Nanda, M.D. · FHI 360

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • Dominican Republic

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05174884 on ClinicalTrials.gov