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

Phase 1 Active not recruiting 136 enrolled Premier Research Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

Non-randomizedSequentialOpen-labelPrevention

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.

Timeline

Start: 2020-03-03
Primary completion: 2026-03-26
Completion: 2026-03-26

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	levonorgestrel butanoate	Unknown	40 mg	Intramuscular
Subject	levonorgestrel butanoate	Unknown	50 mg	Intramuscular
Subject	levonorgestrel butanoate	Unknown	60 mg	Intramuscular

Indications

No indication recorded.