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

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Testosterone
Buspirone hydrochloride
Sponsored by
Emotional Brain NY Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring HSDD

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • San Diego Sexual Medicine
  • Meridien Research
  • Segal Insitute for Clinical Research
  • Compass Research
  • Meridien Research
  • Annapolis Sexual Wellness Center
  • Maryland Prime Care Physicians
  • Center for Sexual Medicine at Sheppard Pratt
  • Boston Clinical Trials
  • NECCR Fall River LLC
  • Michael A. Werner, MD PC
  • Philadelphia Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Testosterone + Buspirone hydrochloride combination drug

Testosterone + Buspirone hydrochloride combinat

Testosterone + Buspirone Combination Drug

Testosterone +Buspirone Combination Drug

Testosterone

Buspirone

Arm Description

30 subjects administered a placebo

30 subjects are given combination drug (0.25 mg Testosterone + 5 mg Buspirone hydrochloride)

30 subjects are given combination drug (0.25 mg Testosterone + 10 mg Buspirone hydrochloride)

30 subjects are given combination drug (0.5 mg Testosterone + 5 mg Buspirone hydrochloride)

30 subjects are given combination drug (0.5 mg Testosterone + 10 mg Buspirone hydrochloride)

30 subjects are given 0.5 mg Testosterone

30 subjects are given 10 mg Buspirone hydrochloride

Outcomes

Primary Outcome Measures

Satisfactory Sexual Episodes
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
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
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
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
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.

Full Information

First Posted
December 4, 2012
Last Updated
March 28, 2014
Sponsor
Emotional Brain NY Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01743235
Brief Title
Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emotional Brain NY Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
HSDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
30 subjects administered a placebo
Arm Title
Testosterone + Buspirone hydrochloride combination drug
Arm Type
Experimental
Arm Description
30 subjects are given combination drug (0.25 mg Testosterone + 5 mg Buspirone hydrochloride)
Arm Title
Testosterone + Buspirone hydrochloride combinat
Arm Type
Experimental
Arm Description
30 subjects are given combination drug (0.25 mg Testosterone + 10 mg Buspirone hydrochloride)
Arm Title
Testosterone + Buspirone Combination Drug
Arm Type
Experimental
Arm Description
30 subjects are given combination drug (0.5 mg Testosterone + 5 mg Buspirone hydrochloride)
Arm Title
Testosterone +Buspirone Combination Drug
Arm Type
Experimental
Arm Description
30 subjects are given combination drug (0.5 mg Testosterone + 10 mg Buspirone hydrochloride)
Arm Title
Testosterone
Arm Type
Experimental
Arm Description
30 subjects are given 0.5 mg Testosterone
Arm Title
Buspirone
Arm Type
Experimental
Arm Description
30 subjects are given 10 mg Buspirone hydrochloride
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Intervention Type
Drug
Intervention Name(s)
Buspirone hydrochloride
Intervention Description
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Primary Outcome Measure Information:
Title
Satisfactory Sexual Episodes
Description
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
Time Frame
20 Weeks
Secondary Outcome Measure Information:
Title
Sexual satisfaction
Description
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.
Time Frame
20 Weeks
Title
Sexual desire and arousal
Description
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.
Time Frame
20 Weeks
Title
Sexual motivation and inhibition
Description
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.
Time Frame
20 weeks
Title
Safety and toleration
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
San Diego Sexual Medicine
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Segal Insitute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Meridien Research
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
34203
Country
United States
Facility Name
Annapolis Sexual Wellness Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Maryland Prime Care Physicians
City
Stevensville
State/Province
Maryland
ZIP/Postal Code
21666
Country
United States
Facility Name
Center for Sexual Medicine at Sheppard Pratt
City
Townson
State/Province
Maryland
ZIP/Postal Code
22104
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
NECCR Fall River LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Michael A. Werner, MD PC
City
Purchase
State/Province
New York
ZIP/Postal Code
10577
Country
United States
Facility Name
Philadelphia Clinical Research, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States

12. IPD Sharing Statement

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

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