drugset / Trial / NCT00401219

Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation

NCT00401219

RandomizedCrossoverOpen-labelTreatment

Summary

This study will compare the bioavailabity of three new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.

Timeline

Start
2006-11
Primary completion
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject conjugated estrogens Other / unclassified 0.625 mg
Subject medroxyprogesterone acetate Other / unclassified 2.5 mg

Indications

No indication recorded.