- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381251
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Two New Formulations of 0.45 mg/1.5 mg Premarin / Medroxyprogesterone Acetate (MPA) Compared With a Reference Formulation of 0.45mg/1.5mg Premarin / MPA (Prempro™) in Healthy Postmenopausal Women.
This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™.
Prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin and MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy, postmenopausal women ages 35 to 70 years, inclusive.
- Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation. Naturally postmenopausal women must not have had a menstrual period since the age of 54. Surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 5 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.
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Collaborators and Investigators
Investigators
- Study Director: Trial Manager, Wyeth is now a wholly owned subsidiary of Pfizer
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0713E1-134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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