Hypoactive Sexual Desire Disorder in Males (HSDD)
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|ClinicalTrials.gov Identifier: NCT04002661|
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Low Libido||Drug: Flibanserin Drug: Placebo||Phase 2|
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 (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:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Study medication (flibanserin 100 mg or identically matched placebo) will be provided in a randomized fashion. Randomization will be 1:1 with a block size of 4. Each individual kit will contain three bottles of 30 tablets of study medication. Each individual bottle within the kit will be labeled sequentially, for example kit 201 will include three bottles of 30 tablets labeled 201A, 201B, 201C. Kits will be numbered consecutively in the randomized order. Once a patient is confirmed eligible to participate in the study, the site will select the lowest numbered kit that has not been assigned to a subject. Subjects will be provided with the "A" bottle at their first visit. The site will mark the subject's study number on the kit and document which subject received that kit number. As subjects return for interim visits, they will be provided the "B" and "C" bottles from their previously assigned kit.|
|Official Title:||Hypoactive Sexual Desire Disorder in Males (10-18-40-13)|
|Actual Study Start Date :||May 8, 2020|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2025|
Active Comparator: Arm 1 - Active
Participants will take flibanserin 100mg orally every night for approximately 3 months.
Other Name: Addyi
Placebo Comparator: Arm 2 - Placebo
Participants will take a placebo orally every night for approximately 3 months.
- Sexual Desires Inventory-2 (SDI-2) [ Time Frame: 3 months ]Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.
- Patient Health Questionnaire (PHQ-9) [ Time Frame: 3 months ]Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months
- Erectile Function Change [ Time Frame: 3 months ]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
- Sexual Concerns Inventory - Male (SCI-M) questionnaire [ Time Frame: 3 months ]Number of Participants with a significant change of at least 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: Perla Ramirezemail@example.com|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Carolyn Molina 713-986-6122 Carolyn.Molina@bcm.edu|
|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|