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
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
None entered ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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