Study ID: TV46046-WH-10159

Study Title

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

Teva Identifier

TV46046-WH-10159

ClinicalTrials.gov Identifier

NCT04682353

Study Status

Recruiting

Trial Condition(s)

Contraception

Interventions

Drug: TV-46046 | Drug: DeposubQ Provera

Study Description

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.


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Key Participation Requirements

Gender

Female

Age Range

18 Years to 45 Years

Trial Duration

December 14, 2020 - November 2, 2022

Phase

Phase 1

Study Type

Interventional


Location - Where to Participate

You may contact 1-888-483-8279 or email USMedInfo@tevapharm.com to obtain more information about study locations.

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