Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle

Summary

The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months.

Timeline

Start

2016-10-26

Primary completion

2018-12-03

Completion

2018-12-03

Publications

• Halpern V, Wheeless A, Brache V, Lendvay A, Cochon L, Taylor D, Dorflinger LJ. A randomized crossover study to evaluate local tolerability following subcutaneous administration of a new depot medroxyprogesterone acetate contraceptive formulation. Contracept X. 2023 Sep 12;5:100100. doi: 10.1016/j.conx.2023.100100. eCollection 2023.

Drugs

Indications