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NCT01743235 · ClinicalTrials.gov registry record · Phase 2
Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
A Phase 2 study of Hypoactive Sexual Desire Disorder, sponsored by Emotional Brain NY.
- Completed
- Registry status
- Phase 2
- Development phase
- 207
- Enrollment target
- 12
- Study locations
NCT01743235 is a Phase 2 study of Hypoactive Sexual Desire Disorder that has completed, run by Emotional Brain NY. The registered enrollment target is 207 participants, below the 378-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (45% lower). The trial reports 12 study locations across 6 states.
The verdict
NCT01743235, a Phase 2 study of Hypoactive Sexual Desire Disorder, has completed, sponsored by Emotional Brain NY.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 207 participants
- Enrollment target
- 12
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Testosterone
- DRUG Buspirone hydrochloride
Study Locations (12)
Florida
- Meridien Research - Bradenton
- Segal Insitute for Clinical Research - North Miami
- Compass Research - Orlando
- Meridien Research - St. Petersburg
Maryland
- Annapolis Sexual Wellness Center - Annapolis
- Maryland Prime Care Physicians - Stevensville
- Center for Sexual Medicine at Sheppard Pratt - Townson
Massachusetts
- Boston Clinical Trials - Boston
- NECCR Fall River LLC - Fall River
California
- San Diego Sexual Medicine - San Diego
New York
- Michael A. Werner, MD PC - Purchase
Pennsylvania
- Philadelphia Clinical Research, LLC - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01743235
The ClinicalTrials.gov registry entry for NCT01743235 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (45% lower). The listed sponsor is Emotional Brain NY, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypoactive Sexual Desire Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01743235 reports 12 study locations spanning 6 distinct geographic areas - top geographies include Florida, Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01743235 about?
NCT01743235 is a clinical study titled "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. In the present study, the efficac...
What is the current status of trial NCT01743235?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2012-07. Estimated completion is 2013-06.
What conditions does trial NCT01743235 study?
This clinical trial studies the following conditions: Hypoactive Sexual Desire Disorder.
What interventions are being tested in trial NCT01743235?
The interventions under investigation include: Placebo (DRUG), Testosterone (DRUG), Buspirone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01743235?
This trial is sponsored by Emotional Brain NY, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01743235 being conducted?
This trial has 12 study locations across California, Florida, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypoactive Sexual Desire Disorder
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Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
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Read our methodology - how this data is sourced, computed, and verified.
Related
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