Lybrido for Female Sexual Dysfunction

• ClinicalTrials.gov Identifier: NCT01432665
• Recruitment Status: Completed
• First Posted: September 13, 2011
• Last Update Posted: July 29, 2013
• Sponsor: Emotional Brain NY Inc.
• Information provided by (Responsible Party): Emotional Brain NY Inc.

Tracking Information

• First Submitted Date: August 17, 2011
• First Posted Date: September 13, 2011
• Last Update Posted Date: July 29, 2013
• Study Start Date: September 2011
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2011)

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. [ Time Frame: 20 weeks ]

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.

Original Primary Outcome Measures (submitted: September 10, 2011)

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. [ Time Frame: 1 Year ]

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.

Current Secondary Outcome Measures (submitted: September 13, 2011)

• Sexual satisfaction [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: September 10, 2011)

• Sexual satisfaction [ Time Frame: 1 year ]
  Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period.
• Sexual desire and arousal [ Time Frame: 1 year ]
  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.
• Sexual motivation and inhibition [ Time Frame: 1 year ]
  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.
• Safety and toleration [ Time Frame: 1 year ]
  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].

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lybrido for Female Sexual Dysfunction
• Official Title: Not Provided
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Hypoactive Sexual Desire Disorder

Intervention

• Drug: Placebo
  Solid Oral Dosage. Maximum every other day (on an as needed basis)
• Drug: Sildenafil
  Solid Oral Dosage. Maximum every other day (on an as needed basis)
• Drug: Testosterone
  Solid Oral Dosage. Maximum every other day (on an as needed basis)

Study Arms

• Experimental: Placebo
  30 subjects administered a placebo
  Intervention: Drug: Placebo
• Experimental: sildenafil + testosterone combination drug 1
  30 subjects are given combination drug 1 (sildenafil 25mg and testosterone 0.25mg)
  Interventions:

  • Drug: Sildenafil
  • Drug: Testosterone
• Experimental: Sildenafil and testosterone combination drug 2
  Sildenafil 50mg and testosterone 0.25mg
  Interventions:

  • Drug: Sildenafil
  • Drug: Testosterone
• Experimental: Sildenafil and testosterone combination drug 3
  30 subjects are given sildenafil 25mg and testosterone 0.50mg
  Interventions:

  • Drug: Sildenafil
  • Drug: Testosterone
• Experimental: Sildenafil and Testosterone Combination drug 4
  30 subjects are given sildenafil 50mg and testosterone 0.50mg
  Interventions:

  • Drug: Sildenafil
  • Drug: Testosterone
• Experimental: Sildenafil 50mg
  30 subjects are given sildenafil 50mg
  Intervention: Drug: Sildenafil
• Experimental: Testosterone 0.50mg
  30 subjects are given testosterone 0.5mg
  Intervention: Drug: Testosterone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 26, 2013): 196
• Original Estimated Enrollment (submitted: September 10, 2011): 210
• Study Completion Date: Not Provided
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01432665
• Other Study ID Numbers: EB82
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Emotional Brain NY Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Emotional Brain NY Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Emotional Brain NY Inc.
• Verification Date: July 2013