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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
Flibanserin tablet
Oral Tablet
Baylor College of Medicine
Houston, Texas, United States
Sexual Desires Inventory-2 (SDI-2)
Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.
Time frame: 3 months
Patient Health Questionnaire (PHQ-9)
Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months
Time frame: 3 months
Erectile Function Change
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
Time frame: 3 months
Sexual Concerns Inventory - Male (SCI-M) questionnaire
Number of Participants with a significant change of at least 2 points higher than at screening.
Time frame: 3 months
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