Official Title: “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”

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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Premarin®/MPA formulation A
• Drug: Premarin®/MPA formulation B
• Drug: Premarin®/MPA formulation C
• Drug: Premarin®/MPA currently marketed product

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Active Comparator: 4

Primary Measures

• Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations
  • Time Frame: 14 weeks
    Safety Issue?: No

Secondary Measures

• No secondary outcome
  • Time Frame: No time frame
    Safety Issue?: No

• Inclusion
• 1. Healthy postmenopausal women aged 35 to 70.
• 2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
• 3. Nonsmoker or smoker of fewer than 10 cigarettes/day.
• Exclusion
• 1. History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.
• 2. History within 1 year of study day 1 of alcohol or drug abuse.
• 3. Use of any investigational drug within 30 days before study day 1.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Overall Contact: Trial Manager  clintrialparticipation@wyeth.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00630435

Study ID Number: 0713E1-1137

ClinicalTrials.gov Identifier: NCT00630435

Health Authority: United States: Food and Drug Administration