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 SatisfactionSexual 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
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