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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 : Recruiting
First Posted : June 28, 2019
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Sprout Pharmaceuticals, Inc
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine

Study Description
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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:

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 Design
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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: 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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1 - Active
Participants will take flibanserin 100mg orally every night for approximately 3 months.
 Drug: Flibanserin
Flibanserin tablet
Other Name: Addyi
Placebo Comparator: Arm 2 - Placebo
Participants will take a placebo orally every night for approximately 3 months.
 Drug: Placebo
Oral Tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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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 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 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
Contacts and Locations
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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: Perla Ramirez 713-7988514 perla.ramirez@bcm.edu

Locations
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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         
Sponsors and Collaborators
Mohit Khera
Sprout Pharmaceuticals, Inc
Investigators
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Principal Investigator: Mohit Khera, MD, MBA, MPH Baylor College of Medicine
More Information
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Responsible Party: Mohit Khera, Professor of Urology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04002661    
Other Study ID Numbers: H-44634
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
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