Evaluate the Pharmacokinetics of Medroxyprogesterone Acetate Following an Injection of TV-46046

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
Completed
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