Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
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
1 other identifier
interventional
207
1 country
12
Brief 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. 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. The number of satisfying sexual events will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone. Lybridos, as compared to placebo, will significantly increase sexual desire/arousal. Sexual desire/arousal will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone. Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase the number of satisfying sexual events and sexual desire/arousal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2012
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMarch 31, 2014
March 1, 2014
11 months
December 4, 2012
March 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Satisfactory Sexual Episodes
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
20 Weeks
Secondary Outcomes (4)
Sexual satisfaction
20 Weeks
Sexual desire and arousal
20 Weeks
Sexual motivation and inhibition
20 weeks
Safety and toleration
20 weeks
Study Arms (7)
Placebo
EXPERIMENTAL30 subjects administered a placebo
Testosterone + Buspirone hydrochloride combination drug
EXPERIMENTAL30 subjects are given combination drug (0.25 mg Testosterone + 5 mg Buspirone hydrochloride)
Testosterone + Buspirone hydrochloride combinat
EXPERIMENTAL30 subjects are given combination drug (0.25 mg Testosterone + 10 mg Buspirone hydrochloride)
Testosterone + Buspirone Combination Drug
EXPERIMENTAL30 subjects are given combination drug (0.5 mg Testosterone + 5 mg Buspirone hydrochloride)
Testosterone +Buspirone Combination Drug
EXPERIMENTAL30 subjects are given combination drug (0.5 mg Testosterone + 10 mg Buspirone hydrochloride)
Testosterone
EXPERIMENTAL30 subjects are given 0.5 mg Testosterone
Buspirone
EXPERIMENTAL30 subjects are given 10 mg Buspirone hydrochloride
Interventions
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Eligibility Criteria
You may qualify if:
- Subjects must meet all of the following criteria:
- Provision of written informed consent
- 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.
- Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 5 for definition)
- Be involved in a stable relationship and have a partner who will be accessible for the majority of the study duration
- Healthy with normal medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
You may not qualify if:
- Subjects who meet any of the following criteria are not eligible to participate in the study:
- Cardiovascular Conditions
- Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
- 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
- Systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 50 mmHg. Gynecological and Obstetric Conditions
- Use of any contraceptive containing antiandrogens (e.g. Cyproteron acetate) or(anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
- Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 μg/day of estrogen
- Positive test result for Chlamydia or gonorrhea
- 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.)
- Lactating or delivery in the previous 6 months prior to signing Informed Consent Form
- Significant abnormal Pap smear in the previous 12 months prior to signing Informed Consent Form
- History of bilateral oophorectomy
- Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
- 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
- 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)
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
San Diego Sexual Medicine
San Diego, California, 92120, United States
Meridien Research
Bradenton, Florida, 34208, United States
Segal Insitute for Clinical Research
North Miami, Florida, 33161, United States
Compass Research
Orlando, Florida, 32806, United States
Meridien Research
St. Petersburg, Florida, 34203, United States
Annapolis Sexual Wellness Center
Annapolis, Maryland, 21401, United States
Maryland Prime Care Physicians
Stevensville, Maryland, 21666, United States
Center for Sexual Medicine at Sheppard Pratt
Townson, Maryland, 22104, United States
Boston Clinical Trials
Boston, Massachusetts, 02135, United States
NECCR Fall River LLC
Fall River, Massachusetts, 02720, United States
Michael A. Werner, MD PC
Purchase, New York, 10577, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 6, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
March 31, 2014
Record last verified: 2014-03