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.
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
