Hypoactive Sexual Desire Disorder in Males

NCT04002661 | Terminated Phase 2 FDA Drug

• 1 other identifier: H-44634
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Libido

Keywords

Low libido; Erectile Dysfunction; Sexual desire

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months

• 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

  3 months

Secondary Outcomes (2)

• Erectile Function Change

  3 months

• Sexual Concerns Inventory - Male (SCI-M) questionnaire

  3 months

Study Arms (2)

Arm 1 - Active

ACTIVE COMPARATOR

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

Drug: Flibanserin

Arm 2 - Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

Oral Tablet

Arm 2 - Placebo

Flibanserin DRUG

Flibanserin tablet

Also known as: Addyi

Arm 1 - Active

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: Men who have a low libido defined by the SDI-2 (Sexual Desires Index-2), and SCI-M (Sexual Conerns Inventory - Male) questionnaires.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: collaborator
• Mohit Khera: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Mohit Khera, MD, MBA, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Urology

Model Details: Arm 1 will receive investigational product. Arm 2 will receive placebo.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: June 28, 2019
• Study Start: May 8, 2020
• Primary Completion: October 31, 2025
• Study Completion: January 23, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)