Hypoactive Sexual Desire Disorder in Males (HSDD)

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

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).

Study Overview

• Status: Terminated
• Conditions: Low Libido
• Intervention / Treatment: Drug: Placebo; Drug: Flibanserin

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: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Addyi
Placebo Comparator: Arm 2 - Placebo; Participants will take a placebo orally every night for approximately 3 months.	Drug: Placebo; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
Sexual Concerns Inventory - Male (SCI-M) questionnaire	Number of Participants with a significant change of at least 2 points higher than at screening.	3 months

Collaborators and Investigators

• Sponsor: Mohit Khera
• Collaborators: Sprout Pharmaceuticals, Inc
• Investigators: Principal Investigator: Mohit Khera, MD, MBA, MPH, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2020
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): January 23, 2026

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Low libido; Sexual desire
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction; flibanserin
• Other Study ID Numbers: H-44634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant date for all primary and secondary outcome measures will be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No