Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

Verified by: Wyeth is now a wholly owned subsidiary of Pfizer, June 2010
First Received: October 3, 2007 | Last Updated: June 17, 2010 | Phase: Phase 1 | Start Date: October 2007
Overall Status: Completed | Estimated Enrollment: 30
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The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA)...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
  • Study Primary Completion Date: December 2007

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

Outcome Measures for this Clinical Trial

Primary Measures

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

Criteria for Participation in this Clinical Trial

  • 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

Clinical Trial Investigator Information

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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