Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
NCT00543634
Last updated date
ABOUT THIS STUDY
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of
Premarin®/medroxyprogesterone (MPA).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Postmenopause
Sex
Female
Age
35-70 years
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Advanced Information
Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
| |||
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 | 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 |
| |||
Sex/Gender ICMJE |
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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 |
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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 |