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
Sponsored by: Wyeth
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
The purpose of this study is to determine bioequivalence and bioavailability of four
different Premarin/MPA test formulations versus the current formulation for Prempro.
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
Minimum age: 35 Years.
Maximum age: 70 Years.
1. Healthy postmenopausal women aged 35 to 70 years
2. Nonsmoker or smoker of less than 10 cigarettes per day
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
Starting date: June 2005
Last updated: September 26, 2006