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

Sponsor

Emotional Brain NY Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01743235

Collaborator

(none)

207

Enrollment

Locations

Arms

Duration (Months)

17.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder	Drug: Placebo Drug: Testosterone Drug: Buspirone hydrochloride	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

207 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Satisfactory Sexual Episodes [20 Weeks]
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 [20 Weeks]
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 [20 Weeks]
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 [20 weeks]
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 [20 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
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 (DSM-IV-TR))
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).
A score of > 65 at the STAI-Y2 questionnaire
Positive test result for illicit drugs Concomitant Medications
Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole clarithromycin, erythromycin and saquinavir)
Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St John"s wort, rifampin)
Use of selective serotonin reuptake inhibitors, tricyclic antidepressants or other antidepressants
Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid],spironolactone)
Use of medication (including herbs) that would compromise the validity of study results
Use of testosterone therapy within 6 months before study entry prior to signing the Informed Consent Form General
Illiteracy, unwillingness, or inability to follow study procedures
Participation in other clinical trials within the last 30 days
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

Locations

	Site	City	State	Country	Postal Code
1	San Diego Sexual Medicine	San Diego	California	United States	92120
2	Meridien Research	Bradenton	Florida	United States	34208
3	Segal Insitute for Clinical Research	North Miami	Florida	United States	33161
4	Compass Research	Orlando	Florida	United States	32806
5	Meridien Research	St Petersburg	Florida	United States	34203
6	Annapolis Sexual Wellness Center	Annapolis	Maryland	United States	21401
7	Maryland Prime Care Physicians	Stevensville	Maryland	United States	21666
8	Center for Sexual Medicine at Sheppard Pratt	Townson	Maryland	United States	22104
9	Boston Clinical Trials	Boston	Massachusetts	United States	02135
10	NECCR Fall River LLC	Fall River	Massachusetts	United States	02720
11	Michael A. Werner, MD PC	Purchase	New York	United States	10577
12	Philadelphia Clinical Research, LLC	Philadelphia	Pennsylvania	United States	19114