Hypoactive Sexual Desire Disorder in Males

Inclusion Criteria:

• Men age 18 through 69 years old

• Men who are distressed by their low libido as defined by SDI-2, and SCI-Mquestionnaires. (Appendices A,C)

• Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) scoreof 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 testosteronetherapy)

• Men who are satisfied in their relationship or with their partners

• Men or their female partners must be willing to use one form of contraceptionthroughout 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 isprohibited 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 theCYP3A4 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 orgreater.

• 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 theirparticipation in the study

• Men who are taking digoxin