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A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception

NCT07222228 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-10-29

No results posted yet for this study

Summary

This is a multicenter, open-label, Phase 2b study to evaluate the efficacy and safety of 2 LB SQ injections administered at a 4-month (approximately 17 weeks) interval for female contraception.

Conditions

  • Healthy Women
  • Female Contraception

Interventions

DRUG

Levonorgestrel butanoate

60 mg SQ (70 mg/mL)

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Premier Research

    lead OTHER

Principal Investigators

  • Diana Blithe, PhD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-12-31
Completion
2029-03-31
FDA Drug
Yes

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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 NCT07222228 on ClinicalTrials.gov