NCT00830414

Medroxyprogesterone Acetate Injection 150 mg/1 mL in Postmenopausal Women

A Pivotal Study to Evaluate the Bioequivalence of 150 mg/1 mL Medroxyprogesterone Acetate Injection in Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	medroxyprogesterone acetate	IM Injection
DRUG	medroxyprogesterone acetate	IM injection

Timeline

• Start date: 2002-04-01
• Primary completion: 2002-09-01
• Completion: 2002-09-01
• First posted: 2009-01-27
• Last updated: 2024-08-19

Locations

1 site across 1 country: Germany