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NCT00472927 Clinical Trial

Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

Postmenopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00472927
Other study ID # 0713E1-1142
Secondary ID
Status Completed
Phase Phase 1
First received May 10, 2007
Last updated December 4, 2007
Start date May 2007
Est. completion date August 2007

Study information
Verified date December 2007
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 Interventional

Clinical Trial Summary

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 70 Years
Eligibility 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 =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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Premarin/MPA 0.45 mg/1.5 mg

Locations
Country Name City State
n/a

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

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)
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