Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

Completed

• Conditions: Postmenopause

• Registration Number: NCT00380887
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Status Verified: 2006-09
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Last Update Submitted: 2006-09-26
• Study First Posted: 2006-09-27
• Last Update Posted: 2006-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

1. Healthy postmenopausal women aged 35 to 70 years
2. Nonsmoker or smoker of less than 10 cigarettes per day

Exclusion Criteria

1. History or presence of clotting disorders
2. History or presence of cancer
3. Presence of HIV, hepatitis B or hepatitis C
4. History of drug or alcohol abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified