Overview

A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age

Status:
Recruiting

Trial end date:
2022-11-02

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The secondary objectives of the study are to evaluate and compare the safety, local tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The total duration of the study for each participant is expected to be up to 19.5 months.

Phase:

Phase 1

Details

Lead Sponsor:

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborator:

FHI 360

Treatments:

Medroxyprogesterone
Medroxyprogesterone Acetate