Status:
COMPLETED
Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Menopause
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
Brief Summary
The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® \[TM...
Eligibility Criteria
Inclusion
- Inclusion
- Healthy postmenopausal women aged 35 to 70.
- Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
- Nonsmoker or smoker of fewer than 10 cigarettes/day.
- Exclusion
- History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.
- History within 1 year of study day 1 of alcohol or drug abuse.
- Use of any investigational drug within 30 days before study day 1.
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00630435
Start Date
February 1 2008
End Date
June 1 2008
Last Update
February 4 2009
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