Researchers at Baylor College of Medicine are conducting a study to determine if a drug will increase sexual desire in men with Hypoactive Sexual Desire Disorder (HSDD). The pilot randomized placebo controlled study will include 60 men: 30 treatment subjects and 30 placebo subjects.
The purpose of this study is to determine if the study drug, Flibanserin (ADDYI), will increase sexual desire in men with HSDD. Study participants will be divided into two arms. Arm 1 participants will receive the study drug to be taken by mouth once a night every night. Arm 2 participants will receive a placebo drug to be taken by mouth once a night every night.
Inclusion criteria for the study consists of men ages 18 to 69 years old. Based on patient questionnaires, additional criteria includes:
- Men that are distressed by their low libido
- Men who are not depressed
- Men with good erectile function
- Men with normal testosterone and liver function values
- 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
Participants are required to make four visits to the Scott Department of Urology at Baylor. The first is a screening that includes a physical, vital signs, blood drawings, concomitant medications (medication participants are taking prior to participating in the study) and questionnaires. Participants will make a second visit nearly a week later, consisting of a physical, vital signs, randomization, drug dispensing, pill diary dispensing and concomitant medications. The third visit entails a physical, vital signs, blood drawings, and drug accountability, pill diary review and medication dispensing. The final visit at the end of the study also includes a physical, vital signs and blood drawings, as well as concomitant medications, questionnaires, drug accountability and a pill diary review.