NCT02101203

Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder

A Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Investigate the Safety and Efficacy of Lybridos in the Domestic Setting in Healthy Female Subjects With Hypoactive Sexual Desire Disorder and Maladaptive Activity of Sexual Inhibitory Mechanisms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Emotional Brain NY Inc. · Industry
• Sex: Female
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms. This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013). In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours after each sexual activity. The following hypotheses will be tested: Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual events. Objectives: To investigate the efficacy of Lybridos as compared to placebo in increasing the number of satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire disorder (HSDD) and maladaptive activity of sexual inhibitory mechanisms * To identify the optimal dose of Lybridos to take into phase 3 clinical development * To confirm that Lybridos has superior efficacy as compared to testosterone alone and to buspirone alone * To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or sexual desire/arousal * To evaluate the safety profile of Lybridos

Detailed description

None entered

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	0.5 mgTestosterone + 10 mg Buspirone	A total of 28 doses will be provided. Subjects are required to take a minimum of 8 doses over the 8-week treatment period (1 dose/week). The other 20 doses may be taken as desired (ie, "on demand") throughout the 8-week treatment period; dosing is permitted every 2 days (ie, on alternate days).

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-08-01
• Completion: 2014-10-01
• First posted: 2014-04-02
• Last updated: 2015-03-24

Locations

10 sites across 1 country: United States