NCT02817464

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

A Two-part, Phase 1, Exploratory and Dose-range Finding Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following a Single Subcutaneous Administration of TV-46046 in Women With Ovulatory Cycle

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy
• Contraception

Interventions

Type	Name	Description
DRUG	TV-46046 - 400 mg/mL	A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL
DRUG	TV-46046 - 200 mg/mL	A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL

Timeline

• Start date: 2016-10-26
• Primary completion: 2018-12-03
• Completion: 2018-12-03
• First posted: 2016-06-29
• Last updated: 2024-02-12
• Results posted: 2024-02-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study