Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postmenopause

Age range

35 year–70 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy postmenopausal women aged 35 to 70 years
Nonsmoker or smoker of less than 10 cigarettes per day

Exclusion criteria

History or presence of clotting disorders
History or presence of cancer
Presence of HIV, hepatitis B or hepatitis C
History of drug or alcohol abuse

Treatment and study plan

Premarin

Drug

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2005
First posted: Sep 27, 2006
Registry last updated: Sep 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed