Postmenopause Clinical Trial
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
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 70 Years |
Eligibility |
- 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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer | MDS Pharma Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). | 4 days | No |
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