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

This study has been completed.
Sponsor:
Collaborator:
MDS Pharma Services
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00543634
First received: October 3, 2007
Last updated: June 17, 2010
Last verified: June 2010
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543634

Locations
United States, Nebraska
Omaha, Nebraska, United States, 68154
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
MDS Pharma Services
Investigators
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00543634     History of Changes
Other Study ID Numbers: 0713E1-1138
Study First Received: October 3, 2007
Last Updated: June 17, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013