Clinical Trial

A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception

Active, Not Recruiting Phase 1
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Record status
This record was last updated October 29, 2025 (before its estimated March 26, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ and then 60 mg SQ depending on the preliminary pharmacokinetic and pharmacodynamic results obtained with 40 mg dosing.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2019-10-28; most recent amendment 2025-10-27.
Status change: Recruiting → Active, Not Recruiting 2025-10-27
Status change: Not Yet Recruiting → Recruiting 2021-05-19
Trial Details
NCT Number NCT04143659
Lead Sponsor Premier Research
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Healthy Women, Female Contraception
Enrollment 136 participants
Start Date 2020-03-03
Primary Completion 2026-03-26 (estimated)
Study Completion 2026-03-26 (estimated)
Updated on ClinicalTrials.gov 2025-10-29