Official Title: “An Open-Label, Single-Dose, Randomized, 4-Period, Partial Crossover Bioequivalence/Bioavailability Study Among Four New Formulations of Premarin 0.45 mg/Medroxyprogesterone Acetate (MPA) 1.5 mg Compared With a Reference Formulation of Premarin/MPA (Prempro) 0.45 mg/1.5 mg in Healthy Postmenopausal Women”

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

Study Type: Observational

Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study

Intervention(s) in this Clinical Trial

• Drug: Premarin

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

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  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00380887

Study ID Number: 0713E1-133, 0713E1-135

ClinicalTrials.gov Identifier: NCT00380887

Health Authority: United States: Institutional Review Board