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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
207
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Solid Oral Dosage. Maximum every other day (on an as needed basis)
San Diego Sexual Medicine
San Diego, California, United States
Meridien Research
Bradenton, Florida, United States
Segal Insitute for Clinical Research
North Miami, Florida, United States
Compass Research
Orlando, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Annapolis Sexual Wellness Center
Annapolis, Maryland, United States
Maryland Prime Care Physicians
Stevensville, Maryland, United States
Center for Sexual Medicine at Sheppard Pratt
Townson, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
NECCR Fall River LLC
Fall River, Massachusetts, United States
...and 2 more locations
Satisfactory Sexual Episodes
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
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 motivation and inhibition
Sexual motivation and inhibition will be assessed using the Sexual Motivation Questionnaire and comparing sexual motivation and inhibition between the 4-week establishment period and 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
Safety and toleration
Safety will be evaluated by: 1) AEs \[Number of patients reporting AEs, number of patients reporting drug related AEs\] 2)SAE \[Number of patients reporting SAEs, number of patients reporting drug related SAEs\]and 3) Changes in laboratory safety data \[Number of patients reporting abnormal lab safety data, number of patients reporting drug related abnormal lab safety data\]. These will be evaluated throughout the course of the study.
Time frame: 20 weeks
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