NCT00630435

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

An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	Premarin®/MPA formulation A
DRUG	Premarin®/MPA formulation B
DRUG	Premarin®/MPA formulation C
DRUG	Premarin®/MPA currently marketed product

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-03-07
• Last updated: 2009-02-04