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

Primary objectives:
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.

Secondary objectives:
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.

Print

Participation criteria and map of study locations


Key Participation Requirements

Gender
Female
Age group
Adult
Age Range
18 Years to 45 Years
Trial Duration
December 14, 2020 - November 2, 2022
Phase
Phase 1

Study Type

Interventional