Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypoactive Sexual Desire Disorder

In brief

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.

Key facts

Study ID

NCT01743235

Run by

Emotional Brain NY Inc.

People needed

207

Starts

2012-07-01

Expected to finish

2013-06-01

Last updated by the study team

2014-03-31

Who can join

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

You may qualify if…

• Subjects must meet all of the following criteria:
• Provision of written informed consent
• Females between 21 and 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained health care professional.
• Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 5 for definition)
• Be involved in a stable relationship and have a partner who will be accessible for the majority of the study duration
• Healthy with normal 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…

• Subjects who meet any of the following criteria are not eligible to participate in the study:
• Cardiovascular Conditions
• Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
• 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. Gynecological and Obstetric Conditions
• Use of any contraceptive containing antiandrogens (e.g. Cyproteron acetate) or(anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
• Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 μg/day of estrogen
• 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 of child bearing potential prior to the administration of study medications.)
• Lactating or delivery in the previous 6 months prior to signing Informed Consent Form
• Significant abnormal Pap smear in the previous 12 months prior to signing Informed Consent Form
• History of bilateral oophorectomy
• Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
• Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night sweating) in combination with elevated FSH levels (>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms) Other Medical Conditions
• Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase > 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) < 60.00 mL/min based on the Cockcroft-Gault formula)
• Any current endocrine disease or endocrinopathy (e.g. uncontrolled thyroid dysfunction) as determined by medical history, basic physical examination and/or laboratory values significantly outside normal range of the central laboratory; or uncontrolled diabetes mellitus (HbA1c > 7.5%)
• Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory (free testosterone: > 1.1 ng/dL, and total testosterone > 80 ng/dL)
• Any current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results or which exclude from use of buspirone and/or testosterone
• History of hormone-dependent malignancy (including all types of breast cancer)
• Vision impairment, such as partial or complete blindness or color blindness
• Dyslexia
• Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
• History of serotonin syndrome Psychological/Psychiatric Factors
• History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered
• (Psychotherapeutic and/or pharmacological 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 buspirone and/or testosterone use

Where it is running

• 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
• Michael A. Werner, MD PC — Purchase, New York, United States
• Philadelphia Clinical Research, LLC — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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