Lybrido for Female Sexual Dysfunction

NCT ID: NCT01432665

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30

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).

Conditions

Hypoactive Sexual Desire Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

30 subjects administered a placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

sildenafil + testosterone combination drug 1

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

Group Type: EXPERIMENTAL

Sildenafil

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Testosterone

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Sildenafil and testosterone combination drug 2

Sildenafil 50mg and testosterone 0.25mg

Group Type: EXPERIMENTAL

Sildenafil

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Testosterone

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Sildenafil and testosterone combination drug 3

30 subjects are given sildenafil 25mg and testosterone 0.50mg

Group Type: EXPERIMENTAL

Sildenafil

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Testosterone

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Sildenafil and Testosterone Combination drug 4

30 subjects are given sildenafil 50mg and testosterone 0.50mg

Group Type: EXPERIMENTAL

Sildenafil

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Testosterone

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Sildenafil 50mg

30 subjects are given sildenafil 50mg

Group Type: EXPERIMENTAL

Sildenafil

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Testosterone 0.50mg

30 subjects are given testosterone 0.5mg

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Interventions

Placebo

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Intervention Type: DRUG

Sildenafil

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Intervention Type: DRUG

Testosterone

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Emotional Brain NY Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

San Diego Sexual Medicine

San Diego, California, United States

The Center for Vulvovaginal Disorders

Washington D.C., District of Columbia, 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

Miami Research Associates

South Miami, Florida, United States

Meridien Research

St. Petersburg, Florida, United States

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States

Annapolis Sexual Wellness Center

Annapolis, Maryland, United States

Maryland Prime Care Physicians

Stevensville, Maryland, United States

Center for Sexual Medicine at Sheppard Pratt

Townson, Maryland, United States

Women's Health Research Center

Plainsboro, New Jersey, United States

Michael A. Werner, MD PC

Purchase, New York, United States

Philadelphia Clinical Research

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

EB82

Identifier Type: -

Identifier Source: org_study_id