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Serotonin Receptor Agonist

Flibanserin for Low Libido in Men (HSDD Trial)

Phase 2
Recruiting
Led By Mohit Khera, MD, MBA, MPH
Research Sponsored by Mohit Khera
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D)
Men age 18 through 69 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

HSDD Trial Summary

This trial is testing whether a drug can increase sexual desire in men with HSDD. Half the participants will take the drug and half will take a placebo.

Who is the study for?
This trial is for men aged 18-69 with low sexual desire causing distress, not due to depression or erectile dysfunction. Participants must have normal testosterone and liver function, be in a satisfying relationship, agree to use contraception during the study and for 30 days after, and cannot be taking certain medications that affect drug metabolism.Check my eligibility
What is being tested?
The study aims to see if Flibanserin can boost sexual desire in men with Hypoactive Sexual Desire Disorder (HSDD). Half of the participants will receive Flibanserin while the other half will get a placebo. The effectiveness is measured by changes in libido.See study design
What are the potential side effects?
Possible side effects of Flibanserin may include sleepiness, dizziness, nausea, fatigue, insomnia and dry mouth. It's important not to drink alcohol as it increases the risk of severe low blood pressure and fainting.

HSDD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man and my depression score is 9 or less.
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I am a man aged between 18 and 69.

HSDD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient Health Questionnaire (PHQ-9)
Sexual Desires Inventory-2 (SDI-2)
Secondary outcome measures
Erectile Function Change
Sexual Concerns Inventory - Male (SCI-M) questionnaire

HSDD Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Arm 1 - ActiveActive Control1 Intervention
Participants will take flibanserin 100mg orally every night for approximately 3 months.
Group II: Arm 2 - PlaceboPlacebo Group1 Intervention
Participants will take a placebo orally every night for approximately 3 months.

Find a Location

Who is running the clinical trial?

Mohit KheraLead Sponsor
2 Previous Clinical Trials
15 Total Patients Enrolled
Sprout Pharmaceuticals, IncIndustry Sponsor
13 Previous Clinical Trials
11,264 Total Patients Enrolled
Mohit Khera, MD, MBA, MPHPrincipal Investigator - Baylor College of Medicine
CHI St. Luke's Health-Baylor St. Luke's Medical Center, Michael E. DeBakey VA Medical Center, St Luke's Diagnostic Cath Lab LLP
University Of Texas Medical School At San Antonio (Medical School)
Baylor College Of Medicine (Residency)

Media Library

Flibanserin (Serotonin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04002661 — Phase 2
Low Libido Research Study Groups: Arm 1 - Active, Arm 2 - Placebo
Low Libido Clinical Trial 2023: Flibanserin Highlights & Side Effects. Trial Name: NCT04002661 — Phase 2
Flibanserin (Serotonin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04002661 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks and side-effects of Arm 1 - Active?

"While Phase 2 trials don't have much data supporting efficacy, the Arm 1 - Active did receive a score of 2 for safety."

Answered by AI

Are there any other ongoing or completed trials that are similar to Arm 1 - Active?

"Currently, there are 2 trials active for Arm 1 - Active. These trials are located in Birmingham, Alabama."

Answered by AI

What is the primary research question of this study?

"Arm 1 - Active has been researched since 2020. The very first trial occurred in 2020 and was sponsored by Sprout Pharmaceuticals, Inc. Following the first trial in 2020, which involved 60 patients, Arm 1 - Active received its Phase 2 drug approval. Today there are 2 live studies underway for Arm 1 - Active across 2 cities in 1 countries."

Answered by AI

If an adult is below the age of 45, can they still participate in this research project?

"The age restrictions for this particular clinical trial are that patients must be between 18-69 years old."

Answered by AI

Are there specific requirements for people who want to join this trial?

"Individuals that wish to partake in this clinical study must have a decreased libido and be between 18-69 years old. Presently, the trial is looking for around 60 more patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hypoactive Sexual Desire Disorder in Males
Mohit Khera 2020. "Hypoactive Sexual Desire Disorder in Males". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04002661.
~7 spots leftby Oct 2024
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