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Hypoactive Sexual Desire Disorder in Males (HSDD)

Primary Purpose

Low Libido

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Flibanserin

Placebo

About this trial

This is an interventional treatment trial for Low Libido focused on measuring Low libido, Erectile Dysfunction, Sexual desire

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1 - Active

Arm 2 - Placebo

Arm Description

Participants will take flibanserin 100mg orally every night for approximately 3 months.

Participants will take a placebo orally every night for approximately 3 months.

Outcomes

Primary Outcome Measures

Sexual Desires Inventory-2 (SDI-2)

Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.

Patient Health Questionnaire (PHQ-9)

Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months

Secondary Outcome Measures

Erectile Function Change

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

Number of Participants with a significant change of at least 2 points higher than at screening.

Full Information

NCT ID

NCT04002661

First Posted

April 24, 2019

Last Updated

February 13, 2023

Sponsor

Mohit Khera

Collaborators

Sprout Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04002661

Brief Title

Hypoactive Sexual Desire Disorder in Males

Acronym

HSDD

Official Title

Hypoactive Sexual Desire Disorder in Males (10-18-40-13)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 8, 2020 (Actual)

Primary Completion Date

October 31, 2024 (Anticipated)

Study Completion Date

October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mohit Khera

Collaborators

Sprout Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Libido

Keywords

Low libido, Erectile Dysfunction, Sexual desire

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Arm 1 will receive investigational product. Arm 2 will receive placebo.

Masking

ParticipantCare ProviderInvestigator

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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 - Active

Arm Type

Active Comparator

Arm Description

Participants will take flibanserin 100mg orally every night for approximately 3 months.

Arm Title

Arm 2 - Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will take a placebo orally every night for approximately 3 months.

Intervention Type

Drug

Intervention Name(s)

Flibanserin

Other Intervention Name(s)

Addyi

Intervention Description

Flibanserin tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral Tablet

Primary Outcome Measure Information:

Title

Sexual Desires Inventory-2 (SDI-2)

Description

Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.

Time Frame

3 months

Title

Patient Health Questionnaire (PHQ-9)

Description

Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Erectile Function Change

Description

Time Frame

3 months

Title

Sexual Concerns Inventory - Male (SCI-M) questionnaire

Description

Number of Participants with a significant change of at least 2 points higher than at screening.

Time Frame

3 months

10. Eligibility

Sex

Male

Gender Based

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.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohit Khera, MD, MBA, MPH

Phone

713-798-6593

mkhera@bcm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Haarika Gudlavalleti

Phone

713-7984398

haarika.gudlavalleti@bcm.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohit Khera, MD, MBA, MPH

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haarika Gudlavalleti

Phone

713-986-4398

haarika.gudlavalleti@bcm.edu

First Name & Middle Initial & Last Name & Degree

Tabish Iqbal

Phone

713-798-8514

tiqbal@bcm.edu

First Name & Middle Initial & Last Name & Degree

Mohit Khera, MD, MBA, MPH

First Name & Middle Initial & Last Name & Degree

Larry I. Lipshultz, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

De-identified individual participant date for all primary and secondary outcome measures will be made available.

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Hypoactive Sexual Desire Disorder in Males

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