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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543634
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : June 22, 2010
MDS Pharma Services
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Postmenopause Drug: Premarin/MPA Drug: Provera 10 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Premarin/MPA
0.625 mg/2.5 mg X4
Drug: Premarin/MPA
0.625 mg/5 mg X 2
Active Comparator: 2 Drug: Provera 10 mg
2.5 mg of MPA, 4 tablets dissoved in water

Primary Outcome Measures :
  1. Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543634

United States, Nebraska
Omaha, Nebraska, United States, 68154
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
MDS Pharma Services
Study Director: Pfizer Call Center Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth Identifier: NCT00543634     History of Changes
Other Study ID Numbers: 0713E1-1138
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Medroxyprogesterone Acetate
Estrogens, Conjugated (USP)
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral