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Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
NCT02101203 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02101203
The ClinicalTrials.gov registry entry for NCT02101203 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emotional Brain NY, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02101203 reports 10 study locations spanning 5 distinct geographic areas — top geographies include Florida, Maryland, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02101203?
The interventions under investigation include: Placebo (DRUG), 0.5 mgTestosterone + 10 mg Buspirone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02101203?
This trial is sponsored by Emotional Brain NY, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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