Lybrido for Female Sexual Dysfunction

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypoactive Sexual Desire Disorder

In brief

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).

Key facts

Study ID

NCT01432665

Run by

Emotional Brain NY Inc.

People needed

196

Starts

2011-09-01

Last updated by the study team

2013-07-29

Who can join

Age: 21 and older, up to 70. Sex: female. Healthy volunteers: accepted.

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
• Current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results, or which could form a contraindication for sildenafil and/or testosterone use
• History of hormone-dependent malignancy
• Vision impairment, such as partial or complete blindness or color blindness
• Dyslexia
• Positive test result for human immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
• History of (childhood) sexual abuse that, in the opinion of the investigator, could have negative psychological effects when testosterone is administered
• (Treatment for) a psychiatric disorder that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for sildenafil and/or testosterone use
• Current psychotherapeutic treatment for female sexual dysfunction
• Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision).
• A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study (Mild or moderate alcohol consumption is allowed but must be stopped 12 hours before the home measurement [Stroop task].)

Where it is running

• San Diego Sexual Medicine — San Diego, California, United States
• The Center for Vulvovaginal Disorders — Washington D.C., District of Columbia, United States
• Meridien Research — 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
• Center for Sexual Medicine at Sheppard Pratt — Townson, Maryland, United States
• Women's Health Research Center — Plainsboro, New Jersey, United States
• Michael A. Werner, MD PC — Purchase, New York, United States
• Philadelphia Clinical Research — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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