Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women

Uterine Leiomyomata (Fibroids) Clinical Trial

Official title: A Randomized, Placebo-Controlled, Double-Blind, Sponsor-Unblinded, Multiple-Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PRA-027 Administered Orally To Cycling Or Postmenopausal Women

Status Completed

Clinical Trial Summary

This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyomata (Fibroids)

• NCT number: NCT00543790
• Study type: Interventional
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Status: Completed
• Phase: Phase 1
• Start date: November 2007
• Completion date: December 2008