Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
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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. |
ClinicalTrials.gov Identifier: NCT00380887 |
Recruitment Status :
Completed
First Posted : September 27, 2006
Last Update Posted : September 27, 2006
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Condition or disease | Intervention/treatment |
---|---|
Postmenopause | Drug: Premarin |
Study Type : | Observational |
Enrollment : | 54 participants |
Observational Model: | Defined Population |
Time Perspective: | Other |
Official Title: | An Open-Label, Single-Dose, Randomized, 4-Period, Partial Crossover Bioequivalence/Bioavailability Study Among Four New Formulations of Premarin 0.45 mg/Medroxyprogesterone Acetate (MPA) 1.5 mg Compared With a Reference Formulation of Premarin/MPA (Prempro) 0.45 mg/1.5 mg in Healthy Postmenopausal Women |
Study Start Date : | June 2005 |


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Ages Eligible for Study: | 35 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy postmenopausal women aged 35 to 70 years
- Nonsmoker or smoker of less than 10 cigarettes per day
Exclusion Criteria:
- History or presence of clotting disorders
- History or presence of cancer
- Presence of HIV, hepatitis B or hepatitis C
- History of drug or alcohol abuse

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 ClinicalTrials.gov identifier (NCT number): NCT00380887
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00380887 |
Other Study ID Numbers: |
0713E1-133, 0713E1-135 |
First Posted: | September 27, 2006 Key Record Dates |
Last Update Posted: | September 27, 2006 |
Last Verified: | September 2006 |
bioavailability bioequivalence marketed product Premarin |
Medroxyprogesterone acetate MPA Postmenopausal vasomotor symptoms |
Estrogens, Conjugated (USP) Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |