Leflutrozole for Hypogonadotropic Hypogonadism

(ETNA Trial)

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?

The goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men with hypogonadotropic hypogonadism, a condition that affects hormone levels and fertility. It will also study the safety of leflutrozole. The main questions it aims to answer are: * Does leflutrozole improve semen quality? * What medical problems do participants experience when taking leflutrozole? Researchers will compare leflutrozole to a placebo (a look-alike substance that contains no drug). Participants will: * Take leflutrozole or a placebo orally once a week for 16 weeks. * Visit the clinic every 4 weeks for checkups and tests. * Provide semen samples to measure changes in semen quality. * Have their blood tested to measure hormone levels and ensure safety. * Be monitored for any side effects.

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