TERMINATED

Hypoactive Sexual Desire Disorder in Males

Conditions

Low Libido Erectile Dysfunction Sexual desire

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD. Half of the participants will take ADDYI while the other half will receive a placebo (a look-alike pill with no medicine).

Official Title

Hypoactive Sexual Desire Disorder in Males (10-18-40-13)

Quick Facts

Study Start:2020-05-08

Study Completion:2026-01-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04002661

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 69 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Men age 18 through 69 years old * Men who are distressed by their low libido as defined by SDI-2, and SCI-M questionnaires. (Appendices A,C) * Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D) * Men with good erectile function as defined by IIEF greater than 22 * Men with normal testosterone and liver function values (may be on testosterone therapy) * Men who are satisfied in their relationship or with their partners * Men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit. * Willing to give informed consent	* Hypogonadal patients (less than 350 ng/dL) * IIEF-EF less than 22 * CYP3A4 and CYP2C19 inhibitors Use of moderate or strong CYP3A4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the CYP3A4 inhibitor * Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT * Men with normal to high libido * Depressed patients as assessed by the PHQ-9 questionnaire as defined as 10 or greater. * Men who are stressed or fatigued as determined by the PI * Men with partners who have low libido as determined by the PI * Men with pre-existing conditions that might predispose to hypertension * Men who are not willing to meet the requirements for drinking alcohol during their participation in the study * Men who are taking digoxin

Inclusion Criteria

Exclusion Criteria

* Men age 18 through 69 years old
* Men who are distressed by their low libido as defined by SDI-2, and SCI-M questionnaires. (Appendices A,C)
* Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D)
* Men with good erectile function as defined by IIEF greater than 22
* Men with normal testosterone and liver function values (may be on testosterone therapy)
* Men who are satisfied in their relationship or with their partners
* Men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit.
* Willing to give informed consent

* Hypogonadal patients (less than 350 ng/dL)
* IIEF-EF less than 22
* CYP3A4 and CYP2C19 inhibitors Use of moderate or strong CYP3A4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the CYP3A4 inhibitor
* Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT
* Men with normal to high libido
* Depressed patients as assessed by the PHQ-9 questionnaire as defined as 10 or greater.
* Men who are stressed or fatigued as determined by the PI
* Men with partners who have low libido as determined by the PI
* Men with pre-existing conditions that might predispose to hypertension
* Men who are not willing to meet the requirements for drinking alcohol during their participation in the study
* Men who are taking digoxin

Contacts and Locations

Principal Investigator

Mohit Khera, MD, MBA, MPH

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Mohit Khera

Mohit Khera, MD, MBA, MPH, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-08

Study Completion Date2026-01-23

Study Record Updates

Study Start Date2020-05-08

Study Completion Date2026-01-23

Terms related to this study

Keywords Provided by Researchers

Low libido
Erectile Dysfunction
Sexual desire

Additional Relevant MeSH Terms

Low Libido