Hypoactive Sexual Desire Disorder in Males

Phase 2

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm 1 - Active	Flibanserin	Participants will take flibanserin 100mg orally every night for approximately 3 months.
Arm 2 - Placebo	Placebo	Participants will take a placebo orally every night for approximately 3 months.

Primary Outcome Measures

Name	Time	Method
Sexual Desires Inventory-2 (SDI-2)	3 months	Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.
Patient Health Questionnaire (PHQ-9)	3 months	Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months

Secondary Outcome Measures

Name	Time	Method
Erectile Function Change	3 months	Number of Participants with a significant change in erectile function and orgasmic scores of at least 2 points on the International Index of Erectile Function (Questions 2, 11, and 12) domain is considered to be 2 points higher than at screening
Sexual Concerns Inventory - Male (SCI-M) questionnaire	3 months	Number of Participants with a significant change of at least 2 points higher than at screening.

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