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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emotional Brain NY Inc.
ClinicalTrials.gov Identifier:
NCT01743235
First received: December 4, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: Placebo
Drug: Testosterone
Drug: Buspirone hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Emotional Brain NY Inc.:

Primary Outcome Measures:
  • Satisfactory Sexual Episodes [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Sexual satisfaction [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    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.

  • Sexual desire and arousal [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    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.

  • Sexual motivation and inhibition [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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.

  • Safety and toleration [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 207
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
30 subjects administered a placebo
Drug: Placebo
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Experimental: Testosterone + Buspirone hydrochloride combination drug
30 subjects are given combination drug (0.25 mg Testosterone + 5 mg Buspirone hydrochloride)
Drug: Testosterone
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Drug: Buspirone hydrochloride
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Experimental: Testosterone + Buspirone hydrochloride combinat
30 subjects are given combination drug (0.25 mg Testosterone + 10 mg Buspirone hydrochloride)
Drug: Testosterone
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Drug: Buspirone hydrochloride
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Experimental: Testosterone + Buspirone Combination Drug
30 subjects are given combination drug (0.5 mg Testosterone + 5 mg Buspirone hydrochloride)
Drug: Testosterone
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Drug: Buspirone hydrochloride
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Experimental: Testosterone +Buspirone Combination Drug
30 subjects are given combination drug (0.5 mg Testosterone + 10 mg Buspirone hydrochloride)
Drug: Testosterone
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Drug: Buspirone hydrochloride
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Experimental: Testosterone
30 subjects are given 0.5 mg Testosterone
Drug: Testosterone
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Experimental: Buspirone
30 subjects are given 10 mg Buspirone hydrochloride
Drug: Buspirone hydrochloride
Solid Oral Dosage. Maximum every other day (on an as needed basis)

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria:

  1. Provision of written informed consent
  2. 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.
  3. Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 5 for definition)
  4. Be involved in a stable relationship and have a partner who will be accessible for the majority of the study duration
  5. 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

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible to participate in the study:

Cardiovascular Conditions

  1. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
  2. 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
  3. Systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 50 mmHg. Gynecological and Obstetric Conditions
  4. Use of any contraceptive containing antiandrogens (e.g. Cyproteron acetate) or(anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
  5. Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 μg/day of estrogen
  6. Positive test result for Chlamydia or gonorrhea
  7. 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.)
  8. Lactating or delivery in the previous 6 months prior to signing Informed Consent Form
  9. Significant abnormal Pap smear in the previous 12 months prior to signing Informed Consent Form
  10. History of bilateral oophorectomy
  11. Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
  12. 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
  13. 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)
  14. 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%)
  15. 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)
  16. 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
  17. History of hormone-dependent malignancy (including all types of breast cancer)
  18. Vision impairment, such as partial or complete blindness or color blindness
  19. Dyslexia
  20. Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
  21. History of serotonin syndrome Psychological/Psychiatric Factors
  22. History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered
  23. (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
  24. Current psychotherapeutic treatment for female sexual dysfunction
  25. Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision (DSM-IV-TR))
  26. 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 Stroop task).
  27. A score of > 65 at the STAI-Y2 questionnaire
  28. Positive test result for illicit drugs Concomitant Medications
  29. Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole clarithromycin, erythromycin and saquinavir)
  30. Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St John‟s wort, rifampin)
  31. Use of selective serotonin reuptake inhibitors, tricyclic antidepressants or other antidepressants
  32. Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid],spironolactone)
  33. Use of medication (including herbs) that would compromise the validity of study results
  34. Use of testosterone therapy within 6 months before study entry prior to signing the Informed Consent Form General
  35. Illiteracy, unwillingness, or inability to follow study procedures
  36. Participation in other clinical trials within the last 30 days
  37. Any other clinically significant abnormality or condition which, in the opinion of the investigator, might interfere with the participant‟s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for buspirone and/or testosterone use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743235

Locations
United States, California
San Diego Sexual Medicine
San Diego, California, United States, 92120
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34208
Segal Insitute for Clinical Research
North Miami, Florida, United States, 33161
Compass Research
Orlando, Florida, United States, 32806
Meridien Research
St Petersburg, Florida, United States, 34203
United States, Maryland
Annapolis Sexual Wellness Center
Annapolis, Maryland, United States, 21401
Maryland Prime Care Physicians
Stevensville, Maryland, United States, 21666
Center for Sexual Medicine at Sheppard Pratt
Townson, Maryland, United States, 22104
United States, Massachusetts
Boston Clinical Trials
Boston, Massachusetts, United States, 02135
NECCR Fall River LLC
Fall River, Massachusetts, United States, 02720
United States, New York
Michael A. Werner, MD PC
Purchase, New York, United States, 10577
United States, Pennsylvania
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States, 19114
Sponsors and Collaborators
Emotional Brain NY Inc.
  More Information

No publications provided

Responsible Party: Emotional Brain NY Inc.
ClinicalTrials.gov Identifier: NCT01743235     History of Changes
Other Study ID Numbers: EB90, EB90
Study First Received: December 4, 2012
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emotional Brain NY Inc.:
HSDD

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Buspirone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 15, 2014