Clinical trial NCT04002661: Hypoactive Sexual Desire Disorder in Males
Official title: Hypoactive Sexual Desire Disorder in Males (10-18-40-13)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Low Libido
Keywords: Low libido
Erectile Dysfunction
Sexual desire
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Sprout Pharmaceuticals, Inc
First posted: 2019-06-28
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1 will receive investigational product.

Arm 2 will receive placebo.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: This pilot randomized placebo controlled study will include 60 men (30 treatment and 30 placebo). ARM 1 will take flibanserin 100mg orally every night and ARM 2 will take a placebo orally every night.

There will be four study visits and the study duration is approximately 4 months. Participants will have physicals at each visit. Blood draws for tests will be done at 3 visits and up to 4 questionnaires will completed at each visit. Study drug will randomized.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sexual Desires Inventory-2 (SDI-2)
timeFrame: 3 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months
Secondary outcomes:
measure: Erectile Function Change
timeFrame: 3 months
measure: Sexual Concerns Inventory - Male (SCI-M) questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Mohit Khera, MD, MBA, MPH
role: PRINCIPAL_INVESTIGATOR
References: