Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 11:38 AM
Study NCT ID:
NCT02101203
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
Sponsor:
Emotional Brain NY Inc.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None entered
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: