Hypoactive Sexual Desire Disorder in Males (HSDD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04002661|
Recruitment Status : Not yet recruiting
First Posted : June 28, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Low Libido||Drug: Flibanserin Drug: Placebo||Phase 2|
Randomization will be determined by the scores of a questionnaire. ARM 1 will take flibanserin (ADDYI) 100mg orally every night and ARM 2 will take a placebo orally every night.
ADDYI is FDA approved to be used in women with HSDD. Some studies have been conducted in males but more information is needed.
There will be four study visits and the study duration is 6 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Arm 1 will receive investigational product.
Arm 2 will receive placebo.
|Masking Description:||Men with a score of 24 on the dyadic domain of the Sexual Desire Inventory (SDI-2) (a score representing the lowest third of scores in the original validation study)1 and a score of 2, 3, or 4 (2 = moderately, 3 = quite a bit, 4 = extremely) on question 12 of the Sexual Concerns Inventory-Male (SCI-M) would be eligible for inclusion in the low sexual desire and distress group. Subjects with odd Subject ID (Identification) numbers will be assigned to Arm 1 (treatment) and those with even ID#s will be assigned to Arm 2 (placebo).|
|Official Title:||Hypoactive Sexual Desire Disorder in Males (10-18-40-13)|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2025|
Active Comparator: Arm 1 - Active
Participants will take flibanserin 100mg orally every night for approximately 6 months.
Other Name: Addyi
Placebo Comparator: Arm 2 - Placebo
Participants will take a placebo orally every night for approximately 6 months.
- A change in International Index of Erectile Function (IIEF) libido domain scores [ Time Frame: 6 months ]Range: 0-30. Number of Participants with a significant change of at least 2 points higher than at screening.
- Sexual Desires Inventory-2 (SDI-2) [ Time Frame: 6 months ]Range: 2-10. Number of Participants with a significant change of at least 2 points higher than at screening.
- Sexual Concerns Inventory - Male (SCI-M) questionnaire [ Time Frame: 6 months ]Range: 2-10. A change in SCI-M score by at least 2 points higher than at screening.
- Erectile Function Change [ Time Frame: 6 months ]Range: 0-30. A significant change in erectile function and orgasmic scores on the International Index of Erectile Function domain is considered to be 4 points higher than at screening.
- Organismic Change [ Time Frame: 6 months ]Range: 0-10 A significant change in erectile function and orgasmic scores on the International Index of Erectile Organism domain is considered to be 2 points higher than at screening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002661
|Contact: Mohit Khera, MD, MBA, MPHfirstname.lastname@example.org|
|Contact: Linda C Higgins, CCRPemail@example.com|
|United States, Texas|
|Baylor College of Medicine||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Linda C. Higgins, CCRP 713-798-4079 firstname.lastname@example.org|
|Contact: Perla Ramirez 713-798-8514 Perla.Ramirez@bcm.edu|
|Principal Investigator: Mohit Khera, MD, MBA, MPH|
|Sub-Investigator: Larry I. Lipshultz, MD|
|Principal Investigator:||Mohit Khera, MD, MBA, MPH||Baylor College of Medicine|