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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: Completed Phase 2 study of Hypoactive Sexual Desire Disorder, sponsored by Emotional Brain NY.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT01743235 record still lists
NCT01743235 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 378-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (45% lower).
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 lists 12 locations in 6 states (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
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01743235's enrollment target sits among peer trials
207 5th of 8 higher than 4 of 8 other Hypoactive Sexual Desire Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoactive Sexual Desire Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
COMPLETED · Phase 2
-
Lybrido for Female Sexual Dysfunction
COMPLETED · Phase 2
-
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
COMPLETED · Phase 3
-
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
COMPLETED · Phase 3
-
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
COMPLETED · Phase 3
-
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
COMPLETED · Phase 3
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