Lybrido for Female Sexual Dysfunction
1 other identifier
interventional
196
1 country
14
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedJuly 29, 2013
July 1, 2013
1.7 years
August 17, 2011
July 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
20 weeks
Secondary Outcomes (4)
Sexual satisfaction
20 Weeks
Sexual desire and arousal
20 Weeks
Sexual motivation and inhibition
20 Weeks
Safety and toleration
20 Weeks
Study Arms (7)
Placebo
EXPERIMENTAL30 subjects administered a placebo
sildenafil + testosterone combination drug 1
EXPERIMENTAL30 subjects are given combination drug 1 (sildenafil 25mg and testosterone 0.25mg)
Sildenafil and testosterone combination drug 2
EXPERIMENTALSildenafil 50mg and testosterone 0.25mg
Sildenafil and testosterone combination drug 3
EXPERIMENTAL30 subjects are given sildenafil 25mg and testosterone 0.50mg
Sildenafil and Testosterone Combination drug 4
EXPERIMENTAL30 subjects are given sildenafil 50mg and testosterone 0.50mg
Sildenafil 50mg
EXPERIMENTAL30 subjects are given sildenafil 50mg
Testosterone 0.50mg
EXPERIMENTAL30 subjects are given testosterone 0.5mg
Interventions
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Eligibility Criteria
You may qualify if:
- Provision of written informed consent
- Female 21 to 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder and/or female orgasmic disorder \[FOD; only as secondary diagnosis\] is allowed). The diagnosis of HSDD will be established by a trained professional.
- Low sensitivity for sexual cues
- Be involved in a stable relationship and have a partner who will be at home for the majority of the study duration
- Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
You may not qualify if:
- Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
- History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months
- Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG)
- Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure \> 90 mmHg. For subjects \> 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure \> 90 mmHg
- Systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg
- Use of oral contraceptive containing anti-androgens
- Use of oral contraceptive containing 50 μg estrogen or more
- Positive test result for Chlamydia or gonorrhea
- Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women prior to the administration of study medications.)
- Lactating or delivery in the previous 6 months
- Significant abnormal pap smear in the previous 12 months
- History of bilateral oophorectomy
- Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
- Liver and/or renal insufficiency (aspartate aminotransferase and alanine aminotransferase \> 3 times the upper limit of normal and/or glomerular filtration rate \< 29 mL/min based on the Cockcroft and Gault formula)
- Current clinically relevant endocrine disease or uncontrolled diabetes mellitus
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
San Diego Sexual Medicine
San Diego, California, 92120, United States
The Center for Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037, United States
Meridien Research
Brooksville, Florida, 34601, United States
Segal Institute Women's Health Clinic
North Miami, Florida, 33161, United States
Compass Research
Orlando, Florida, 32806, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Meridien Research
St. Petersburg, Florida, 34203, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Annapolis Sexual Wellness Center
Annapolis, Maryland, 21401, United States
Maryland Prime Care Physicians
Stevensville, Maryland, 21666, United States
Center for Sexual Medicine at Sheppard Pratt
Townson, Maryland, 22104, United States
Women's Health Research Center
Plainsboro, New Jersey, 08536, United States
Michael A. Werner, MD PC
Purchase, New York, 10577, United States
Philadelphia Clinical Research
Philadelphia, Pennsylvania, 19114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2011
First Posted
September 13, 2011
Study Start
September 1, 2011
Primary Completion
May 1, 2013
Last Updated
July 29, 2013
Record last verified: 2013-07