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”

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Study Type: Interventional

Study Design: Health Services Research, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Premarin/MPA
  • 0.625 mg/2.5 mg X4
• Drug: Premarin/MPA
  • 0.625 mg/5 mg X 2
• Drug: Provera 10 mg
  • 2.5 mg of MPA, 4 tablets dissoved in water

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).
  • Time Frame: 4 days
    Safety Issue?: No

• 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

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/NCT00543634

Study ID Number: 0713E1-1138

ClinicalTrials.gov Identifier: NCT00543634

Health Authority: United States: Food and Drug Administration