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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

Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE May 8, 2020
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • A improvement in International Index of Erectile Function (IIEF) libido domain scores [ Time Frame: 6 months ]
    Range: 0-30. Improvement will be considered an increase of at least 2 points.
  • Sexual Desires Inventory-2 (SDI-2) [ Time Frame: 6 months ]
    Range: 2-10. An improvement in SDI-2 score by at least 2 points
  • Sexual Concerns Inventory - Male (SCI-M) questionnaire [ Time Frame: 6 months ]
    Range: 2-10. An improvement in SCI-M score by at least 2 points
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Erectile Function Improvement [ Time Frame: 6 months ]
    Range: 0-30. A significant improvements in erectile function and orgasmic scores on the International Index of Erectile Function domain is considered to be 4 points.
  • Organismic Improvement [ Time Frame: 6 months ]
    Range: 0-10 A significant improvements in erectile function and orgasmic scores on the International Index of Erectile Organism domain is considered to be 2 points.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypoactive Sexual Desire Disorder in Males
Official Title  ICMJE Hypoactive Sexual Desire Disorder in Males (10-18-40-13)
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Low Libido
Intervention  ICMJE
  • Drug: Flibanserin
    Flibanserin tablet
    Other Name: Addyi
  • Drug: Placebo
    Oral Tablet
Study Arms  ICMJE
  • Active Comparator: Arm 1 - Active
    Participants will take flibanserin 100mg orally every night for approximately 3 months.
    Intervention: Drug: Flibanserin
  • Placebo Comparator: Arm 2 - Placebo
    Participants will take a placebo orally every night for approximately 3 months.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2025
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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.
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohit Khera, MD, MBA, MPH 713-798-6593 mkhera@bcm.edu
Contact: Perla Ramirez 713-7988514 perla.ramirez@bcm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002661
Other Study ID Numbers  ICMJE H-44634
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: De-identified individual participant date for all primary and secondary outcome measures will be made available.
Responsible Party Mohit Khera, Baylor College of Medicine
Study Sponsor  ICMJE Mohit Khera
Collaborators  ICMJE Sprout Pharmaceuticals, Inc
Investigators  ICMJE
Principal Investigator: Mohit Khera, MD, MBA, MPH Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP