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NCT02101203 · ClinicalTrials.gov registry record · Phase 2
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
A Phase 2 study of Hypoactive Sexual Desire Disorder, sponsored by Emotional Brain NY.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 10
- Study locations
NCT02101203: Completed Phase 2 study of Hypoactive Sexual Desire Disorder, sponsored by Emotional Brain NY.
NCT02101203 is a Phase 2 study of Hypoactive Sexual Desire Disorder that has completed, run by Emotional Brain NY. The registered enrollment target is 80 participants, below the 394-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (80% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101203, a Phase 2 study of Hypoactive Sexual Desire Disorder, has completed, sponsored by Emotional Brain NY.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 10
- 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. 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
Primary Outcome
Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 0.5 mgTestosterone + 10 mg Buspirone
Study Locations (10)
Florida
- Meridien Research - Bradenton
- Compass Research - Orlando
- Meridien Research - St. Petersburg
- Comprehensive Clinical Trials LLC - West Palm Beach
Maryland
- Annapolis Sexual Wellness Center - Annapolis
- Maryland Center for Sexual Wellness - Lutherville
- Maryland Primary Care Physicians - Queenstown
California
- San Diego Sexual Medicine - San Diego
Massachusetts
- NECCR Fall River LLC - Fall River
Pennsylvania
- Philadelphia Clinical Research, LLC - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT02101203 record still lists
NCT02101203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 394-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Hypoactive Sexual Desire Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02101203 lists 10 locations in 5 states (Florida, Maryland, California).
Frequently Asked Questions
What is clinical trial NCT02101203 about?
NCT02101203 is a clinical study titled "Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder". 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 Lybri...
What is the current status of trial NCT02101203?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2013-07. Estimated completion is 2014-10.
What conditions does trial NCT02101203 study?
This clinical trial studies the following conditions: Hypoactive Sexual Desire Disorder.
What interventions are being tested in trial NCT02101203?
The interventions under investigation include: Placebo (DRUG), 0.5 mgTestosterone + 10 mg Buspirone (DRUG).
Who is sponsoring clinical trial NCT02101203?
This trial is sponsored by Emotional Brain NY, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02101203 being conducted?
This trial has 10 study locations across California, Florida, Maryland, Massachusetts, Pennsylvania. 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 NCT02101203's enrollment target sits among peer trials
80 8th of 8 higher than 1 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 Due to Maladaptive Activation of Sexual Inhibitory Systems
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