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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01432665
Other study ID # EB82
Secondary ID
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. completion date
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
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