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Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:
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

Clinical Trial 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.

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.

The number of satisfying sexual events will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.

Lybridos, as compared to placebo, will significantly increase sexual desire/arousal.

Sexual desire/arousal will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.

Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase the number of satisfying sexual events and sexual desire/arousal.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Hypoactive Sexual Desire Disorder
  • Hypokinesia
  • Sexual Dysfunctions, Psychological
Clinical Trial Details
NCT number NCT01743235
Study type Interventional
Source Emotional Brain NY Inc.
Contact
Status Completed
Phase Phase 2
Start date July 2012
Completion date June 2013
View Details
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