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

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NCT00543634

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Study Location
Omaha, Nebraska, 68154, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmenopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-70 years

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
Official Title  ICMJE 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
Brief Summary The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Postmenopause
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Interventions:
    • Drug: Premarin/MPA
    • Drug: Premarin/MPA
  • Active Comparator: 2
    Intervention: Drug: Provera 10 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 19, 2007)		30
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00543634
Other Study ID Numbers  ICMJE 0713E1-1138
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE MDS Pharma Services
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP