Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

Phase 1

Completed

• Conditions: Postmenopause
• Interventions: Drug: Premarin/MPA; Drug: Provera 10 mg

• Registration Number: NCT00543634
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-03
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-15
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-17
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Premarin/MPA	-
2	Provera 10 mg	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).	4 days