drugset / Trial / NCT00604825

Treatment Of Hot Flashes/Flushes In Postmenopausal Women (WARM Study)

NCT00604825 ↗

Phase 2 Completed 356 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether GSK232802 is safe and effective in reducing the frequency and severity of hot flashes associated with menopause.

Timeline

Start
2007-07-17
Primary completion
2008-07-23
Completion
2008-07-23

Outcome

Mixed primary results

registry analysis (superiority test); Placebo vs GSK232802 75 mg; p = 0.041; Adjusted Mean Difference 1.21 (95% CI 0.05 to 2.37) NCT00604825 ↗

registry analysis (superiority test); Placebo vs GSK232802 75 mg; p = 0.008; Adjusted Mean Difference 0.31 (95% CI 0.08 to 0.54) NCT00604825 ↗

registry analysis (superiority test); Placebo vs GSK232802 25 mg; p = 0.215; Adjusted Mean Difference 0.75 (95% CI -0.44 to 1.93) NCT00604825 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator GSK232802 Small molecule — Oral
Subject conjugated estrogens Other / unclassified — —

Indications

No indication recorded.