Lybrido for Female Sexual Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emotional Brain NY Inc.
ClinicalTrials.gov Identifier:
NCT01432665
First received: August 17, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: Placebo
Drug: Sildenafil
Drug: Testosterone
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Emotional Brain NY Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Sexual satisfaction [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    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.

  • Sexual desire and arousal [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    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.

  • Sexual motivation and inhibition [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    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.

  • Safety and toleration [ Time Frame: 20 Weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 196
Study Start Date: September 2011
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432665

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

No publications provided

Responsible Party: Emotional Brain NY Inc.
ClinicalTrials.gov Identifier: NCT01432665     History of Changes
Other Study ID Numbers: EB82
Study First Received: August 17, 2011
Last Updated: July 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emotional Brain NY Inc.:
HSDD

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Sildenafil
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 20, 2014