A Phase II, multicentre, double-blind, randomised, placebo-controlled trial to demonstrate the efficacy and safety of BP101 in patients with hypoactive sexual desire disorder.

Abstract

This is a multicentre, double-blind, phase II study to evaluate the efficacy, safety and tolerability of BP101, administered as two nasal sprays once daily for 28 days, in pre-menopausal women with HSDD. Participants will be randomly assigned to receive one of three different doses of BP101, or placebo. Study assessments include safety checks including vital signs, physical exam and blood tests, and questionnaires to determine whether BP101 can improve sexual function and desire.