Flibanserin for Low Libido in Men

(HSDD Trial)

Overseen by Mohit Khera, MD, MBA, MPH

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Mohit Khera

Must not be taking: CYP3A4 inhibitors, Digoxin

Disqualifiers: Hypogonadism, Depression, Hypertension, others

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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).

Do I have to stop taking my current medications for this trial?

You may need to stop taking certain medications, especially if you are using moderate or strong CYP3A4 inhibitors, as these are not allowed during the trial. If you need to take such medications, you must stop the study drug for two weeks after your last dose of the inhibitor. If you are taking digoxin, you cannot participate in the trial.

Is Flibanserin safe for humans?

Flibanserin is considered reasonably safe for humans, but it can cause sedation (drowsiness) and has safety concerns like low blood pressure and fainting, especially when mixed with alcohol. ^{1 2 3 4 5}

How is the drug flibanserin unique for treating low libido in men?

Flibanserin is unique because it works by affecting brain chemicals like serotonin, dopamine, and noradrenaline, which is different from other treatments that might focus on hormonal changes. It is originally approved for women with low sexual desire, making its use in men a novel approach. ^{1 2 3 4 6}

Research Team

Mohit Khera, MD, MBA, MPH

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I have good erectile function.

Willing to give informed consent

I am willing to use contraception during and for 30 days after the study.

Exclusion Criteria

I am a man experiencing stress or fatigue as confirmed by my doctor.

I am not taking strong medications that affect liver enzymes during the trial.

I am a man with conditions that could lead to high blood pressure.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either flibanserin 100mg or placebo orally every night for approximately 3 months

3 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Flibanserin (Serotonin Receptor Agonist)
• Placebo (Other)

Trial Overview 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.

Participant Groups

Group I: Arm 1 - Active Active Control 1 Intervention

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

Group II: Arm 2 - Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Mohit Khera

Lead Sponsor

Trials

3

Recruited

80+

Sprout Pharmaceuticals, Inc

Industry Sponsor

Trials

14

Recruited

11,300+

Findings from Research

Flibanserin (Addyi) was approved by the FDA in 2015 for treating hypoactive sexual desire disorder (HSDD) in premenopausal women, but its approval has been surrounded by controversies regarding its safety and efficacy.

The review suggests that flibanserin is modestly effective and reasonably safe, although there are ongoing debates about the validity of clinical trials and the philosophical implications of diagnosing and treating low libido.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flibanserin and its discontents. Aftab, A., Chen, C., McBride, J.[2018]

In a study involving 24 healthy premenopausal women, flibanserin taken at bedtime after moderate alcohol consumption was well-tolerated, showing no significant increase in hypotension or syncope compared to placebo.

The study found that common adverse effects of flibanserin, such as headaches and hypotension, occurred at similar rates regardless of alcohol consumption, indicating that the timing of flibanserin dosing may mitigate risks associated with alcohol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Millheiser, L., Clayton, AH., Parish, SJ., et al.[2020]

In a study involving 64 healthy premenopausal women, flibanserin did not increase the risk of hypotension, orthostatic hypotension, or syncope when taken 2, 4, or 6 hours after moderate alcohol consumption (0.4 g/kg).

The study found no significant differences in adverse events between flibanserin and placebo, suggesting that moderate alcohol intake does not adversely affect the safety profile of flibanserin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. Simon, JA., Clayton, AH., Kingsberg, SA., et al.[2020]

Flibanserin, developed for hypoactive sexual desire disorder in women, shows a strong correlation between its plasma concentrations and sedative effects, with a steep relationship indicating rapid onset of drowsiness after administration.

At plasma concentrations below approximately 200 ng/mL, flibanserin has minimal impact on drowsiness, suggesting that it may be safe for use without significant sedation at lower doses, as observed in a study involving 24 healthy volunteers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic/pharmacodynamic model for the sedative effects of flibanserin in healthy volunteers. Trocóniz, IF., Boland, K., Staab, A.[2021]

Flibanserin (Addyi) is the first drug approved to treat hypoactive sexual desire disorder in women, which affects about 10% of the female population, and showed significant improvements in satisfying sexual events and desire in clinical trials.

Safety concerns were raised regarding side effects like sedation and hypotension, as well as interactions with alcohol and certain medications, leading to additional studies mandated by the FDA before approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flibanserin: From Bench to Bedside. Dooley, EM., Miller, MK., Clayton, AH.[2018]

Flibanserin, approved in the USA for treating hypoactive sexual desire disorder (HSDD) in premenopausal women, works by acting on serotonin receptors to increase dopamine and noradrenaline levels while lowering serotonin levels in the brain.

The drug's earlier development for HSDD in the EU and Canada was halted due to regulatory feedback, and its potential use for depression was also discontinued due to only mild antidepressant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flibanserin: First Global Approval. Deeks, ED.[2018]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Flibanserin and its discontents. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic/pharmacodynamic model for the sedative effects of flibanserin in healthy volunteers. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Flibanserin: From Bench to Bedside. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Flibanserin: First Global Approval. [2018]