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Lybrido for Female Sexual Dysfunction

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Sildenafil
Testosterone
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:

  1. Provision of written informed consent
  2. 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.
  3. Low sensitivity for sexual cues
  4. Be involved in a stable relationship and have a partner who will be at home for the majority of the study duration
  5. 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

Exclusion Criteria:

  1. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
  2. History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months
  3. Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG)
  4. 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
  5. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg
  6. Use of oral contraceptive containing anti-androgens
  7. Use of oral contraceptive containing 50 μg estrogen or more
  8. Positive test result for Chlamydia or gonorrhea
  9. 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.)
  10. Lactating or delivery in the previous 6 months
  11. Significant abnormal pap smear in the previous 12 months
  12. History of bilateral oophorectomy
  13. Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
  14. 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)
  15. Current clinically relevant endocrine disease or uncontrolled diabetes mellitus
  16. 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
  17. History of hormone-dependent malignancy
  18. Vision impairment, such as partial or complete blindness or color blindness
  19. Dyslexia
  20. Positive test result for human immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
  21. History of (childhood) sexual abuse that, in the opinion of the investigator, could have negative psychological effects when testosterone is administered
  22. (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
  23. Current psychotherapeutic treatment for female sexual dysfunction
  24. Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision).
  25. 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].)
  26. Positive test result for illicit drugs
  27. Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole clarithromycin, erythromycin and saquinavir)
  28. Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St John"s wort, rifampin)
  29. Use of nitrates or nitric oxide donor compounds
  30. Use of selective serotonin reuptake inhibitors, tricyclic antidepressants, or other antidepressants
  31. Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid])
  32. Use of medication (including herbs) that would compromise the validity of study results
  33. Use of testosterone therapy within 6 months before study entry
  34. Illiteracy, unwillingness, or inability to follow study procedures
  35. Participation in other clinical trials within the last 30 days
  36. 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 sildenafil and/or testosterone use

Sites / Locations

  • San Diego Sexual Medicine
  • The Center for Vulvovaginal Disorders
  • Meridien Research
  • Segal Institute Women's Health Clinic
  • Compass Research
  • Miami Research Associates
  • Meridien Research
  • Comprehensive Clinical Trials, LLC
  • Annapolis Sexual Wellness Center
  • Maryland Prime Care Physicians
  • Center for Sexual Medicine at Sheppard Pratt
  • Women's Health Research Center
  • Michael A. Werner, MD PC
  • Philadelphia Clinical Research

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

sildenafil + testosterone combination drug 1

Sildenafil and testosterone combination drug 2

Sildenafil and testosterone combination drug 3

Sildenafil and Testosterone Combination drug 4

Sildenafil 50mg

Testosterone 0.50mg

Arm Description

30 subjects administered a placebo

30 subjects are given combination drug 1 (sildenafil 25mg and testosterone 0.25mg)

Sildenafil 50mg and testosterone 0.25mg

30 subjects are given sildenafil 25mg and testosterone 0.50mg

30 subjects are given sildenafil 50mg and testosterone 0.50mg

30 subjects are given sildenafil 50mg

30 subjects are given testosterone 0.5mg

Outcomes

Primary Outcome Measures

The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting.
Efficacy is estimated by self reporting by subjects using daily event questionnaires, recorded within 24 hours after a sexual event. The number of events between a 4-week baseline establishment period will be compared with the number of events during the 8 week double-blind 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.

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
August 17, 2011
Last Updated
July 26, 2013
Sponsor
Emotional Brain NY Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01432665
Brief Title
Lybrido for Female Sexual Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
undefined (undefined)

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
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).

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
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
30 subjects administered a placebo
Arm Title
sildenafil + testosterone combination drug 1
Arm Type
Experimental
Arm Description
30 subjects are given combination drug 1 (sildenafil 25mg and testosterone 0.25mg)
Arm Title
Sildenafil and testosterone combination drug 2
Arm Type
Experimental
Arm Description
Sildenafil 50mg and testosterone 0.25mg
Arm Title
Sildenafil and testosterone combination drug 3
Arm Type
Experimental
Arm Description
30 subjects are given sildenafil 25mg and testosterone 0.50mg
Arm Title
Sildenafil and Testosterone Combination drug 4
Arm Type
Experimental
Arm Description
30 subjects are given sildenafil 50mg and testosterone 0.50mg
Arm Title
Sildenafil 50mg
Arm Type
Experimental
Arm Description
30 subjects are given sildenafil 50mg
Arm Title
Testosterone 0.50mg
Arm Type
Experimental
Arm Description
30 subjects are given testosterone 0.5mg
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)
Sildenafil
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)
Primary Outcome Measure Information:
Title
The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting.
Description
Efficacy is estimated by self reporting by subjects using daily event questionnaires, recorded within 24 hours after a sexual event. The number of events between a 4-week baseline establishment period will be compared with the number of events during the 8 week double-blind 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
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: 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 Exclusion Criteria: 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].) Positive test result for illicit drugs 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 nitrates or nitric oxide donor compounds 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]) Use of medication (including herbs) that would compromise the validity of study results Use of testosterone therapy within 6 months before study entry 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 sildenafil 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
The Center for Vulvovaginal Disorders
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Segal Institute Women's Health Clinic
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
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Meridien Research
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
34203
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
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
Women's Health Research Center
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
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
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lybrido for Female Sexual Dysfunction

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