Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

Phase 1

Completed

• Conditions: Menopause
• Interventions: Drug: Premarin®/MPA formulation A; Drug: Premarin®/MPA formulation B; Drug: Premarin®/MPA formulation C; Drug: Premarin®/MPA currently marketed product

• Registration Number: NCT00630435
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® \[TM\]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Premarin®/MPA formulation A	-
2	Premarin®/MPA formulation B	-
3	Premarin®/MPA formulation C	-
4	Premarin®/MPA currently marketed product	-

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations	14 weeks

Secondary Outcome Measures

Name	Time	Method
No secondary outcome	No time frame