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Tracking Information | |||||
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First Received Date † | May 10, 2007 | ||||
Last Updated Date | December 4, 2007 | ||||
Start Date † | May 2007 | ||||
Current Primary Outcome Measures † |
Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components) | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00472927 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro) | ||||
Official Title † | An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women | ||||
Brief Summary | To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA). |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Crossover Assignment | ||||
Condition † | Postmenopause | ||||
Intervention † | Drug: Premarin/MPA 0.45 mg/1.5 mg | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | August 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 35 Years to 70 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00472927 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Wyeth | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Wyeth | ||||
Verification Date | December 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |