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Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder

Information source: Emotional Brain NY Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypoactive Sexual Desire Disorder

Intervention: Placebo (Drug); 0.5 mgTestosterone + 10 mg Buspirone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Emotional Brain NY Inc.

Summary

A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms. This is a 2-arm placebo and Lybridos (0. 5 mg testosterone + buspirone 10 mg) extension to study EB90 (Clinical Study Protocol EB90a, version 3. 0, 07 June 2013). In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours after each sexual activity. The following hypotheses will be tested: Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual events. Objectives: To investigate the efficacy of Lybridos as compared to placebo in increasing the number of satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire disorder (HSDD) and maladaptive activity of sexual inhibitory mechanisms

- To identify the optimal dose of Lybridos to take into phase 3 clinical development

- To confirm that Lybridos has superior efficacy as compared to testosterone alone and to

buspirone alone

- To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or

sexual desire/arousal

- To evaluate the safety profile of Lybridos

Clinical Details

Official title: A Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Investigate the Safety and Efficacy of Lybridos in the Domestic Setting in Healthy Female Subjects With Hypoactive Sexual Desire Disorder and Maladaptive Activity of Sexual Inhibitory Mechanisms

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ).

Secondary outcome:

Sexual Satisfaction

Sexual desire and arousal

Sexual Distress

Subjective evaluation of gain and improvement

Detailed description: None entered

Eligibility

Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: Subjects must meet all of the following criteria: 1. Provision of written informed consent 2. Females between 21 and 70 years of age, inclusive, pre or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained health care professional. 3. Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 4 for definition) 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: Subjects who meet any of the following criteria are not eligible to participate in the study: Cardiovascular Conditions 1. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity 2. 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 3. Systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 50 mmHg Gynecological and Obstetric Conditions 4. Use of any contraceptive containing anti-androgens (e. g. Cyproteron acetate) or (anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel) 5. Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 μg/day of estrogen 6. Positive test result for Chlamydia or gonorrhea 7. Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women of child bearing potential prior to the administration of study medications.) 8. Lactating or delivery in the previous 6 months prior to signing Informed Consent Form 9. Significant abnormal Pap smear in the previous 12 months prior to signing Informed Consent Form 10. History of bilateral oophorectomy 11. Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns 12. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e. g. hot flashes, night sweating) in combination with elevated FSH levels (>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy perimenopausality can be assessed by FSH levels (>40 IU/L) and/or vasomotor symptoms Other Medical Conditions 13. Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase > 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) < 60. 00 mL/min based on the Cockcroft Gault formula) 14. Any current endocrine disease or endocrinopathy (e. g. uncontrolled thyroid dysfunction) as determined by medical history, basic physical examination and/or laboratory values significantly outside the normal range of the central laboratory; or uncontrolled diabetes mellitus(HbA1c > 7. 5%) 15. Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory (free testosterone: > 1. 1 ng/dL, and total testosterone > 80 ng/dL)

Locations and Contacts

San Diego Sexual Medicine, San Diego, California 92120, United States

Meridien Research, Bradenton, Florida 34208, United States

Compass Research, Orlando, Florida 32806, United States

Meridien Research, St. Petersburg, Florida 33709, United States

Comprehensive Clinical Trials LLC, West Palm Beach, Florida 33409, United States

Annapolis Sexual Wellness Center, Annapolis, Maryland 21401, United States

Maryland Center for Sexual Wellness, Lutherville, Maryland 21093, United States

Maryland Primary Care Physicians, Queenstown, Maryland 21658, United States

NECCR Fall River LLC, Fall River, Massachusetts 02720, United States

Philadelphia Clinical Research, LLC, Philadelphia, Pennsylvania 19224, United States

Additional Information

Starting date: July 2013
Last updated: March 23, 2015

Page last updated: August 20, 2015

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