Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: Premarin/MPA 0.45 mg/1.5 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
To evaluate three new investigational tablet formulations of the Food and Drug Administration
(FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate
(MPA).
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Primary outcome: Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy, postmenopausal women, aged 35 to 70 years
- Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous
amenorrhea for at least 6 months (FSH level â¥38 mIU/mL); spontaneous amenorrhea must
have begun by the age of 55
- BMI in the range of 18 to 35 kg/m2
Exclusion Criteria:
- History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
- History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor
modulators (SERMs)
- Use of prescription or investigatioanl drugs within 30 days before test article
administration
Locations and Contacts
Miami, Florida 33126, United States
Additional Information
Starting date: May 2007
Ending date: August 2007
Last updated: December 4, 2007
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