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NCT00543634 Clinical Trial

Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

Postmenopause Clinical Trial

Official title:
Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00543634
Other study ID # 0713E1-1138
Secondary ID
Status Completed
Phase Phase 1
First received October 3, 2007
Last updated June 17, 2010
Start date October 2007
Est. completion date December 2007

Study information
Verified date June 2010
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 70 Years
Eligibility - Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea

- BMI in the range of 18 to 35 kg/m2

- History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)

- History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)

- Use of any prescription or investigational drug within 30 days before test article administration

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Drug:
• Premarin/MPA
0.625 mg/2.5 mg X4
• Premarin/MPA
0.625 mg/5 mg X 2
• Provera 10 mg
2.5 mg of MPA, 4 tablets dissoved in water

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer MDS Pharma Services

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). 4 days No
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