Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: Premarin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
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
Study design: Screening, Cross-Sectional, Defined Population, Prospective Study
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2005
Last updated: September 26, 2006
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