Hypoactive Sexual Desire Disorder in Men Study (H-44634)

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.

The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD.

Eligibility Criteria

Inclusion criteria

• Men age 18 through 69 years old
• Men that 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 a PHQ-9 (Patient Health Questionnaire) score of ≤9. (Appendices D)
• Men with good erectile function as defined by IIEF-EF >22
• Men with normal testosterone and liver function values (may be on TTh)
• 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 (<350 ng/dL)
• SDI-2 ≥24
• IIEF-EF <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 a PHQ-9 questionnaire score of ≥10
• 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.