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NCT00380887 Clinical Trial

Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

Postmenopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00380887
Other study ID # 0713E1-133, 0713E1-135
Secondary ID
Status Completed
Phase Phase 1
First received September 26, 2006
Last updated September 26, 2006
Start date June 2005

Study information
Verified date September 2006
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria:

1. Healthy postmenopausal women aged 35 to 70 years

2. Nonsmoker or smoker of less than 10 cigarettes per day

Exclusion Criteria:

1. History or presence of clotting disorders

2. History or presence of cancer

3. Presence of HIV, hepatitis B or hepatitis C

4. History of drug or alcohol abuse

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Drug:
• Premarin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer
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