Flibanserin for Low Libido in Men

(HSDD Trial)

Overseen By Larry I. Lipshultz, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Mohit Khera

Must not be taking: CYP3A4 inhibitors, Digoxin

Disqualifiers: Hypogonadism, Depression, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 3 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if flibanserin can boost sexual desire in men experiencing low libido and distress. Participants will take either flibanserin or a placebo (a pill without active medicine) nightly for about three months. Suitable candidates are men distressed by low sex drive, with good erectile function, no depression, and normal testosterone levels. Participants must be in a satisfying relationship and agree to use contraception during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the FDA has approved flibanserin to treat low sexual desire in women, indicating it is reasonably safe for humans. However, flibanserin can cause side effects. Studies have found it may lead to drowsiness, low blood pressure, and even fainting in some individuals.

Despite these effects, the treatment has been successfully used in other groups, providing some confidence in its safety. Prospective trial participants should be aware of these possible side effects. Discuss any concerns with the trial team to make an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for low libido?

Most treatments for low libido in men, like testosterone replacement therapy, primarily focus on hormonal imbalances. But flibanserin works differently, targeting neurotransmitters in the brain to possibly enhance sexual desire. This unique approach could offer a new option for those who don't benefit from traditional hormone-based treatments. Researchers are excited because flibanserin's mechanism of action provides a fresh perspective on managing low libido, potentially helping a wider range of individuals.

What evidence suggests that flibanserin might be an effective treatment for low libido in men?

This trial will compare flibanserin, also known as Addyi, with a placebo to evaluate its effects on low libido in men. Research has shown that flibanserin can boost sexual desire by adjusting brain chemicals like dopamine and serotonin. In women, studies have found that flibanserin leads to more satisfying sexual experiences and better sexual function scores. However, in men, some studies did not show much improvement compared to a placebo in increasing sexual desire. It's important to note that the exact mechanism of flibanserin remains unclear. Early findings suggest that while it is effective for women, its benefits for men are less certain. ^{1 2 6 7 8}

Who Is on the Research Team?

Mohit Khera, MD, MBA, MPH

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Flibanserin
• Placebo

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.

How Is the Trial Designed?

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.

Flibanserin is already approved in United States for the following indications:

Approved in United States as Addyi for:

• Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women

Who Is Running the Clinical Trial?

Mohit Khera

Lead Sponsor

Trials

3

Recruited

80+

Sprout Pharmaceuticals, Inc

Industry Sponsor

Trials

14

Recruited

11,300+

Published Research Related to This Trial

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]

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 (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 (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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4854663/

Flibanserin for Treating Hypoactive Sexual Desire Disorder In both VIOLET6 and DAISY7 studies, flibanserin showed an increase in satisfying sexual events (SSE) and Female Sexual Function Index (FSFI) and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2050052117300677

Review Flibanserin: From Bench to Bedside Review of the process of FDA approval of a medication to treat hypoactive sexual desire disorder and research published exploring the efficacy and safety of ...

3. drugs.com drugs.com/medical-answers/addyi-work-effective-3573766/

How does Addyi work and is it effective? Results demonstrate statistically significant improvements in satisfying sexual events, sexual desire and ability to lower distress in ...

4. mensreproductivehealth.com mensreproductivehealth.com/pt-141-vs-flibanserin-exploring-off-label-treatments-for-low-sex-drive-in-men/

PT-141 VS. FLIBANSERIN: EXPLORING OFF-LABEL ... In fact, in two of the three trials, flibanserin did not significantly outperform placebo in improving self-reported sexual desire intensity or reducing ...

5. addyi.com addyi.com/

Addyi® (flibanserin): HSDD Treatment for Certain ... Addyi helps balance neurotransmitters like dopamine, serotonin, and norepinephrine to support sexual desire. The exact mechanism of action of Addyi is unknown.

6. mayoclinic.org mayoclinic.org/drugs-supplements/flibanserin-oral-route/description/drg-20152672

Flibanserin (oral route) - Side effects & dosage Flibanserin is used to treat hypoactive sexual desire disorder (HSDD) in women who have not gone through menopause. This medicine should only be used by women ...

7. trial.medpath.com trial.medpath.com/clinical-trial/2f61dbbb8bed8bfc/hypoactive-sexual-desire-disorder-males

Hypoactive Sexual Desire Disorder in Males | MedPath 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 ...

8. withpower.com withpower.com/trial/phase-3-sexual-dysfunctions-psychological-4-2020-01c93

Flibanserin for Low Libido in Men (HSDD Trial) Flibanserin is considered reasonably safe for humans, but it can cause sedation (drowsiness) and has safety concerns like low blood pressure and fainting, ...