Hypoactive Sexual Desire Disorder in Males

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hypoactive Sexual Desire Disorder in Males (10-18-40-13)

Conditions
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Low Libido

Intervention / Treatment
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* Drug: Flibanserin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1 will receive investigational product. Arm 2 will receive placebo.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 - Active<br>Participants will take flibanserin 100mg orally every night for approximately 3 months. | Drug: Flibanserin<br>* Flibanserin tablet<br>* Other names: Addyi;|
| Placebo Comparator: Arm 2 - Placebo<br>Participants will take a placebo orally every night for approximately 3 months. | Drug: Placebo<br>* Oral Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low libido, Erectile Dysfunction, Sexual desire