Lybrido for Female Sexual Dysfunction

Hypoactive Sexual Desire Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432665
• Other study ID #: EB82
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2011
• Last updated: July 26, 2013
• Start date: September 2011

Study information

• Verified date: July 2013
• Source: Emotional Brain NY Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Sexual Dysfunctions, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	Annapolis Sexual Wellness Center	Annapolis	Maryland
United States	Meridien Research	Brooksville	Florida
United States	Segal Institute Women's Health Clinic	North Miami	Florida
United States	Compass Research	Orlando	Florida
United States	Philadelphia Clinical Research	Philadelphia	Pennsylvania
United States	Women's Health Research Center	Plainsboro	New Jersey
United States	Michael A. Werner, MD PC	Purchase	New York
United States	San Diego Sexual Medicine	San Diego	California
United States	Miami Research Associates	South Miami	Florida
United States	Meridien Research	St Petersburg	Florida
United States	Maryland Prime Care Physicians	Stevensville	Maryland
United States	Center for Sexual Medicine at Sheppard Pratt	Townson	Maryland
United States	The Center for Vulvovaginal Disorders	Washington	District of Columbia
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Emotional Brain NY Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 weeks	No
Secondary	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.	20 Weeks	No
Secondary	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.	20 Weeks	No
Secondary	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.	20 Weeks	No
Secondary	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.	20 Weeks	Yes