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Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder

NCT02101203 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-03-24

No results posted yet for this 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

  • Hypoactive Sexual Desire Disorder

Interventions

DRUG

Placebo

DRUG

0.5 mgTestosterone + 10 mg Buspirone

A total of 28 doses will be provided. Subjects are required to take a minimum of 8 doses over the 8-week treatment period (1 dose/week). The other 20 doses may be taken as desired (ie, "on demand") throughout the 8-week treatment period; dosing is permitted every 2 days (ie, on alternate days).

Sponsors & Collaborators

  • Emotional Brain NY Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-08-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101203 on ClinicalTrials.gov