Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: Premarin/MPA (Drug); Premarin/MPA (Drug); Provera 10 mg (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations
of Premarin®/medroxyprogesterone (MPA).
Clinical Details
Official title: Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women
Study design: Health Services Research, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
- Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical
amenorrhea
- BMI in the range of 18 to 35 kg/m2
- History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
- History of drug allergy, particularly to conjugated estrogens (CE) or selective
estrogen receptor modulators (SERMs)
- Use of any prescription or investigational drug within 30 days before test article
administration
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Omaha, Nebraska 68154, United States; Recruiting
Additional Information
Starting date: October 2007
Ending date: April 2008
Last updated: July 8, 2009
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