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.
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
