RCT Comparing Efficacy of FP-101 60mg b.i.d. vs. Placebo in Treatment of Moderate/Severe Hot Flashes in Menopausal Women
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101
(60mg b.i.d.), an extended-release d-3-methoxy-N-methyl-morphinan hydrobromide oral tablet
product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in
peri- and post-menopausal women over a period of 1-week.