Medroxyprogesterone Acetate Injection 150 mg/1 mL in Postmenopausal Women
- Registration Number
- NCT00830414
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
This study compared the rates and extents of medroxyprogesterone absorption from two medroxyprogesterone acetate injection formulations following single 150 mg intramuscular (IM) injections to healthy postmenopausal women.
- Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 124
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 medroxyprogesterone acetate - 2 medroxyprogesterone acetate DEPO-PROVERA®
- Primary Outcome Measures
Name Time Method Bioequivalence based on Cmax and AUC 120 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AAI Deutschland GmbH & Co. KG
🇩🇪Neu-Ulm, Germany