NCT00826436

Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women

A Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of PRA-027 Administered Orally to Japanese Postmenopausal Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal women.

Conditions

• Uterine Leiomyomata (Fibroids)

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-01-22
• Last updated: 2009-03-06

Locations

1 site across 1 country: Japan