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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopause

Intervention: Premarin/MPA (Drug); Premarin/MPA (Drug); Provera 10 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Summary

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

Clinical Details

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

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

Primary outcome: Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).

Eligibility

Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

- 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

Locations and Contacts

Omaha, Nebraska 68154, United States
Additional Information

Starting date: October 2007
Last updated: June 17, 2010

Page last updated: August 23, 2015

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