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Hypoactive Sexual Desire Disorder in Males (HSDD)

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ClinicalTrials.gov Identifier: NCT04002661
Recruitment Status : Not yet recruiting
First Posted : June 28, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Sprout Pharmaceuticals, Inc
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Low Libido Drug: Flibanserin Drug: Placebo Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Arm 1 will receive investigational product.

Arm 2 will receive placebo.

Masking: Single (Participant)
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).
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin

Arm Intervention/treatment
Active Comparator: Arm 1 - Active
Participants will take flibanserin 100mg orally every night for approximately 6 months.
Drug: Flibanserin
Flibanserin tablet
Other Name: Addyi

Placebo Comparator: Arm 2 - Placebo
Participants will take a placebo orally every night for approximately 6 months.
Drug: Placebo
Oral Tablet




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men who have a low libido defined by the IIEF (International Index of Erectile Function), SDI-2 (Sexual Desires Index-2), and SCI-M (Sexual Conerns Inventory - Male) questionnaires.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men age 18 through 69 years old
  • Men who have a low libido defined by the IIEF (International Index of Erectile Function), SDI-2, and SCI-M questionnaires. (Appendices 1-3)
  • Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire). (Appendices 4)
  • Men with good erectile function as defined by IIEF >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 (<350 ng/dL)
  • IIEF-EF <22
  • CYP3A4 and CYP2C19 inhibitors
  • Hepatic impairment
  • Men with normal to high libido
  • Depressed patients as assessed by the PHQ-9 questionnaire
  • Men who are stressed or fatigued.
  • Men with partners who have low libido

Information from the National Library of Medicine

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


Contacts
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Contact: Mohit Khera, MD, MBA, MPH 713-798-6593 mkhera@bcm.edu
Contact: Linda C Higgins, CCRP 713-798-4079 lhiggins@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Linda C. Higgins, CCRP    713-798-4079    lhiggins@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         
Sponsors and Collaborators
Mohit Khera
Sprout Pharmaceuticals, Inc
Investigators
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Principal Investigator: Mohit Khera, MD, MBA, MPH Baylor College of Medicine

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Responsible Party: Mohit Khera, Professor of Urology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04002661     History of Changes
Other Study ID Numbers: H-44634
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified individual participant date for all primary and secondary outcome measures will be made available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohit Khera, Baylor College of Medicine:
Low libido
Erectile Dysfunction
Sexual desire

Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Mental Disorders