drugset / Trial / NCT04682353
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
RandomizedParallel-groupDouble-blindOther
Summary
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.
Timeline
- Start
- 2020-12-14
- Primary completion
- 2022-07-11
- Completion
- 2023-01-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Depo-subQ Provera | Unknown | 104 mg | Subcutaneous |
| Subject | medroxyprogesterone acetate | Other / unclassified | 120 mg | Subcutaneous |
| Subject | medroxyprogesterone acetate | Other / unclassified | 180 mg | Subcutaneous |
| Subject | medroxyprogesterone acetate | Other / unclassified | 240 mg | Subcutaneous |
Indications
No indication recorded.