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.

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 (Clinical Trial)
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: September 2011
• Actual Primary Completion Date: May 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. [ 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

San Diego Sexual Medicine

San Diego, California, United States, 92120

United States, District of Columbia

The Center for Vulvovaginal Disorders

Washington, District of Columbia, United States, 20037

United States, Florida

Meridien Research

Brooksville, Florida, United States, 34601

Segal Institute Women's Health Clinic

North Miami, Florida, United States, 33161

Compass Research

Orlando, Florida, United States, 32806

Miami Research Associates

South Miami, Florida, United States, 33143

Meridien Research

St Petersburg, Florida, United States, 34203

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States, 33409

United States, Maryland

Annapolis Sexual Wellness Center

Annapolis, Maryland, United States, 21401

Maryland Prime Care Physicians

Stevensville, Maryland, United States, 21666

Center for Sexual Medicine at Sheppard Pratt

Townson, Maryland, United States, 22104

United States, New Jersey

Women's Health Research Center

Plainsboro, New Jersey, United States, 08536

United States, New York

Michael A. Werner, MD PC

Purchase, New York, United States, 10577

United States, Pennsylvania

Philadelphia Clinical Research

Philadelphia, Pennsylvania, United States, 19114

Sponsors and Collaborators

Emotional Brain NY Inc.

More Information

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

Keywords provided by Emotional Brain NY Inc.:

HSDD

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological; Mental Disorders; Sildenafil Citrate; Testosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Vasodilator Agents; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Urological Agents