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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborator: MDS Pharma Services
• Treatments: Estrogens, Conjugated (USP); Medroxyprogesterone; Medroxyprogesterone Acetate

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