Lybrido for Female Sexual Dysfunction

• Sponsor: Emotional Brain NY Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01432665
• Collaborator: (none)
• Enrollment: 196
• Locations: 14
• Arms: 7
• Patients Per Site: 14

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder	Drug: Placebo; Drug: Sildenafil; Drug: Testosterone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: May 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: sildenafil + testosterone combination drug 1 30 subjects are given combination drug 1 (sildenafil 25mg and testosterone 0.25mg)	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)
Experimental: Sildenafil and testosterone combination drug 2 Sildenafil 50mg and testosterone 0.25mg	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)
Experimental: Sildenafil and testosterone combination drug 3 30 subjects are given sildenafil 25mg and testosterone 0.50mg	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)
Experimental: Sildenafil and Testosterone Combination drug 4 30 subjects are given sildenafil 50mg and testosterone 0.50mg	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)
Experimental: Sildenafil 50mg 30 subjects are given sildenafil 50mg	Drug: Sildenafil; Solid Oral Dosage. Maximum every other day (on an as needed basis)
Experimental: Testosterone 0.50mg 30 subjects are given testosterone 0.5mg	Drug: Testosterone; Solid Oral Dosage. Maximum every other day (on an as needed basis)

Outcome Measures

Primary Outcome Measures

1. 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. [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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego Sexual Medicine	San Diego	California	United States	92120
2	The Center for Vulvovaginal Disorders	Washington	District of Columbia	United States	20037
3	Meridien Research	Brooksville	Florida	United States	34601
4	Segal Institute Women's Health Clinic	North Miami	Florida	United States	33161
5	Compass Research	Orlando	Florida	United States	32806
6	Miami Research Associates	South Miami	Florida	United States	33143
7	Meridien Research	St Petersburg	Florida	United States	34203
8	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida	United States	33409
9	Annapolis Sexual Wellness Center	Annapolis	Maryland	United States	21401
10	Maryland Prime Care Physicians	Stevensville	Maryland	United States	21666
11	Center for Sexual Medicine at Sheppard Pratt	Townson	Maryland	United States	22104
12	Women's Health Research Center	Plainsboro	New Jersey	United States	08536
13	Michael A. Werner, MD PC	Purchase	New York	United States	10577
14	Philadelphia Clinical Research	Philadelphia	Pennsylvania	United States	19114

Sponsors and Collaborators

• Emotional Brain NY Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emotional Brain NY Inc.
• ClinicalTrials.gov Identifier: NCT01432665
• Other Study ID Numbers: EB82
• First Posted: Sep 13, 2011
• Last Update Posted: Jul 29, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Emotional Brain NY Inc.: HSDD
• Additional relevant MeSH terms: Sexual Dysfunctions, Psychological; Sildenafil Citrate; Testosterone

Study Results

No Results Posted as of Jul 29, 2013