The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of Lybrido in increasing the number of satisfactory sexual episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire disorder and low sensitivity for sexual cues (30 subjects per group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
196
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
The Center for Vulvovaginal Disorders
Washington D.C., District of Columbia, United States
Meridien Research
The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting.
Efficacy is estimated by self reporting by subjects using daily event questionnaires, recorded within 24 hours after a sexual event. The number of events between a 4-week baseline establishment period will be compared with the number of events during the 8 week double-blind 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 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.
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Brooksville, Florida, United States
Segal Institute Women's Health Clinic
North Miami, Florida, United States
Compass Research
Orlando, Florida, United States
Miami Research Associates
South Miami, 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 Prime Care Physicians
Stevensville, Maryland, United States
...and 4 more locations
Time frame: 20 Weeks