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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 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.

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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

Conditions Studied

Hypoactive Sexual Desire Disorder

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

FieldValue
Enrollment Target 80 participants
Start Date 2013-07
Est. Completion 2014-10
Phase Phase 2

Sponsor

Emotional Brain NY

3 total trials

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What the Registry Record Tells You About NCT02101203

The ClinicalTrials.gov registry entry for NCT02101203 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 394-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (80% 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 2 interventions - of which Placebo is the first listed.

NCT02101203 reports 10 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.