drugset
drugset / Trial / NCT00630435

Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

NCT00630435 ↗

Phase 1 Completed 76 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedCrossoverOpen-label

Summary

The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® \[TM\]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Timeline

Start
2008-02
Primary completion
2008-06
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject conjugated estrogens Other / unclassified — —
Subject medroxyprogesterone acetate Other / unclassified — —

Indications

No indication recorded.