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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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).
San Diego Sexual Medicine
San Diego, California, United States
Meridien Research
Bradenton, Florida, United States
Compass Research
Orlando, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Comprehensive Clinical Trials LLC
West Palm Beach, Florida, United States
Annapolis Sexual Wellness Center
Annapolis, Maryland, United States
Maryland Center for Sexual Wellness
Lutherville, Maryland, United States
Maryland Primary Care Physicians
Queenstown, Maryland, United States
NECCR Fall River LLC
Fall River, Massachusetts, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States
The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ).
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.
Time frame: 20 weeks
Sexual Satisfaction
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
Time frame: 20 weeks
Sexual desire and arousal
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.
Time frame: 20 weeks
Sexual Distress
Sexual Distress will be assessed using the Female Sexual Distress Scale-Revised (FSDS-R).
Time frame: 20 weeks
Subjective evaluation of gain and improvement
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)
Time frame: 20 weeks
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