Leflutrozole for Hypogonadotropic Hypogonadism

(ETNA Trial)

Recruiting at 2 trial locations

Overseen By Public Disclosure

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: ReproNovo Aps

Must not be taking: Hormone drugs, Alpha blockers

Disqualifiers: Testes abnormalities, Pituitary disease, Prostate disease, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called leflutrozole to determine if it can improve semen quality in men with hypogonadotropic hypogonadism, a condition affecting hormones and fertility. Researchers aim to discover if different doses of leflutrozole are more effective than a placebo and to identify any side effects. Eligible participants have low testosterone levels and a low sperm count and can provide semen samples and attend regular clinic visits. Participants will take the drug or placebo once a week for 16 weeks, with regular checkups to monitor hormone levels and overall safety. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant findings in fertility treatment.

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

Yes, you will need to stop taking certain medications, especially those affecting hormone levels, fertility drugs, and some other specific drugs like testosterone therapy and anabolic steroids, for at least 6 months before the trial.

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

Research has shown that leflutrozole has been tested for safety in people before. In a study involving men with low testosterone due to obesity, leflutrozole helped normalize testosterone levels and supported sperm production. Importantly, participants generally tolerated the treatment well.

While specific safety details from this trial aren't provided, the fact that leflutrozole is in a Phase 2 trial suggests it demonstrated some safety in earlier research. Phase 2 studies typically involve more participants than initial studies and focus on determining the right dose while monitoring for side effects.

If leflutrozole is tested for a different condition than originally intended, it might still be safe, but new uses can have different side effects. Participants should be closely monitored for any health issues during the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Leflutrozole is unique because it uses a novel mechanism to tackle hypogonadotropic hypogonadism. Unlike standard treatments that often involve hormone replacement therapies, Leflutrozole is an aromatase inhibitor, which means it works by preventing the conversion of androgens into estrogen. This can lead to an increase in testosterone levels, which is particularly beneficial for individuals with this condition. Researchers are excited about Leflutrozole's potential to provide a more targeted and potentially more effective treatment option with a once-weekly oral capsule, offering convenience alongside its unique action.

What evidence suggests that leflutrozole might be an effective treatment for hypogonadotropic hypogonadism?

Research has shown that leflutrozole can improve semen quality in men with certain hormone imbalances. In earlier studies, men taking leflutrozole experienced increased semen volume and more active sperm. These improvements suggest that leflutrozole might help with fertility issues related to low hormone levels. Although body shape and sexual function remained unchanged, the improvements in semen quality are promising. Overall, leflutrozole appears to support better sperm production in men with a specific hormone condition called hypogonadotropic hypogonadism. ^{1 2 3 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

ReproNovo Aps

Are You a Good Fit for This Trial?

Men aged 18-49 with hypogonadotropic hypogonadism can join this trial. They must have low testosterone, normal or high levels of certain hormones, and a low sperm count but adequate semen volume. Participants need to understand the study requirements and consent to them.

Inclusion Criteria

I am a man aged between 18 and 49.

I understand and can follow the study's requirements.

I have signed the consent form for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take leflutrozole or a placebo orally once a week for 16 weeks. They visit the clinic every 4 weeks for checkups and tests, provide semen samples, and have their blood tested.

16 weeks

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

• Leflutrozole

Trial Overview The trial is testing three different doses of Leflutrozole against a placebo to see if it improves semen quality in men with hormone imbalances affecting fertility. It involves weekly oral medication for 16 weeks, regular clinic visits, semen analysis, blood tests for safety monitoring.

How Is the Trial Designed?

Group I: Leflutrozole, 0.3 mg Experimental Treatment 1 Intervention

Leflutrozole, 0.3 mg, oral capsule, once weekly for 16 weeks

Group II: Leflutrozole, 0.1 mg Experimental Treatment 1 Intervention

Leflutrozole, 0.1 mg, oral capsule, once weekly for 16 weeks

Group III: Leflutrozole, 0.05 mg Experimental Treatment 1 Intervention

Leflutrozole, 0.05 mg, oral capsule, once weekly for 16 weeks

Group IV: Placebo Placebo Group 1 Intervention

Placebo, oral capsule, once weekly for 16 weeks

Who Is Running the Clinical Trial?

ReproNovo Aps

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06993155

NCT06993155 | A Clinical Trial Evaluating the Efficacy and ... The goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men with hypogonadotropic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37579053/

Leflutrozole in male obesity-associated hypogonadotropic ... No improvements in body composition or sexual dysfunction were observed. Semen volume/total motile sperm count improved with leflutrozole vs ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06993155/a-clinical-trial-evaluating-the-efficacy-and-safety-of-leflutrozole-on-testicular-function-in-men-with-hypogonadotropic-hypogonadism?phase=1&id=64&slug=hormone-deficiencies

A Clinical Trial Evaluating the Efficacy and Safety of ... The goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men with ...

4. urologytimes.com urologytimes.com/view/study-launches-of-first-in-class-aromatase-inhibitor-for-male-infertility

Study launches of first-in-class aromatase inhibitor for male ... A clinical trial evaluating the efficacy and safety of leflutrozole on testicular function in men with hypogonadotropic hypogonadism (ETNA).

5. academic.oup.com academic.oup.com/ejendo/article-abstract/189/3/297/7242426

Leflutrozole in male obesity-associated hypogonadotropic ... No improvements in body composition or sexual dysfunction were observed. Semen volume/total motile sperm count improved with leflutrozole vs ...

6. ctv.veeva.com ctv.veeva.com/study/a-clinical-trial-evaluating-the-efficacy-and-safety-of-leflutrozole-on-testicular-function-in-men-wi

A Clinical Trial Evaluating the Efficacy and Safety of ... The goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men with ...

7. go.drugbank.com go.drugbank.com/drugs/DB19047

Leflutrozole: Uses, Interactions, Mechanism of Action Leflutrozole is under investigation in clinical trial NCT02908074 (A 6 Month Safety Extension Study of MBGS205).