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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Hypo

Brief 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 Summary: None entered
Sponsor: Emotional Brain NY Inc.

Current Primary Outcome: The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ). [ Time Frame: 20 weeks ]

Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Sexual Satisfaction [ Time Frame: 20 weeks ]
    Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks
  • Sexual desire and arousal [ Time Frame: 20 weeks ]
    Sexual desire and arousal will be evaluated based on the 'desire' and 'arousal' domains of the Sexual Anamnesis Questionnaire, the Sexual Function questionnaire and weekly diaries throughout the course of the study.
  • Sexual Distress [ Time Frame: 20 weeks ]
    Sexual Distress will be assessed using the Female Sexual Distress Scale-Revised (FSDS-R).
  • Subjective evaluation of gain and improvement [ Time Frame: 20 weeks ]

    Using the following tools, perceived gain and improvement will be assessed:

    • Subjective Evaluation of Gain (SEG)
    • Subjective Evaluation of Improvement (SEI)
    • Patient's Global Impression of Improvement (PGI-I)
    • Patient Benefit Evaluation (PBE)


Original Secondary Outcome: Same as current

Information By: Emotional Brain NY Inc.

Dates:
Date Received: March 28, 2014
Date Started: July 2013
Date Completion:
Last Updated: March 23, 2015
Last Verified: March 2014