Clomiphene Citrate for Low Testosterone

Overseen By Jonathan Gal, MD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Must not be taking: Hormone-modifying, Estrogen, Testosterone

Disqualifiers: Karyotype abnormality, Kallmann syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

This trial tests clomiphene citrate in men with low testosterone to see if it can naturally boost their hormone levels. The goal is to find a dose that doesn't require daily medication. Clomiphene citrate has been used to increase testosterone levels in men and improve reproductive health.

Do I need to stop my current medications to join the trial?

The trial requires that you have not used hormone-modifying medications like clomiphene citrate, testosterone therapy, or similar treatments. If you are currently on these medications, you would need to stop them to participate.

What data supports the effectiveness of the drug Clomiphene Citrate for low testosterone?

Research shows that Clomiphene Citrate can effectively increase testosterone levels in men with low testosterone, particularly in those with hypogonadism (a condition where the body doesn't produce enough testosterone). It works by stimulating the body's own production of testosterone without affecting fertility. ^{1 2 3 4 5}

Is clomiphene citrate safe for treating low testosterone in men?

Clomiphene citrate is generally considered safe for men with low testosterone, as studies have shown it can increase testosterone levels without the side effects associated with traditional testosterone therapy. It is used off-label for this purpose and has been shown to be a safe alternative, especially for those who wish to maintain fertility. ^{2 6 7 8 9}

How is the drug Clomiphene Citrate unique for treating low testosterone?

Clomiphene Citrate is unique because it stimulates the body's own production of testosterone without suppressing sperm production, unlike traditional testosterone replacement therapies. It is taken orally and is particularly beneficial for men who wish to maintain fertility. ^{2 3 4 8 10}

Research Team

Jonathan Gal, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

Men aged 21-45 with low testosterone (TT < 300 ng/dl) can join this trial. They must have had two tests a week apart showing low levels and be free from serious health issues like heart or liver disease, psychiatric disorders, bleeding problems, and certain hormonal conditions. No history of drug abuse or sensitivity to clomiphene is allowed.

Inclusion Criteria

I am a man aged between 21 and 45.

My testosterone levels are below 300 ng/dl, confirmed by two tests.

Exclusion Criteria

I have had a pituitary tumor or surgery to remove one.

I am allergic to clomiphene or similar medications.

I have had testicular cancer or have undergone orchiectomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clomiphene citrate at either 25 mg daily or 50 mg every other day for 12 weeks

12 weeks

Visits at baseline, day 2, day 4, weeks 1-4, 8, 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Visit at week 16

Treatment Details

Interventions

• Clomiphene Citrate

Trial Overview The trial is testing how the body processes two different doses of Clomiphene Citrate (25mg and 50mg) in men with low testosterone. Participants will be randomly assigned to receive one of the doses in an open-label setting where both they and the researchers know which dose is given.

Participant Groups

Group I: Clomiphene citrate 50 mg every other day for 12 weeks Experimental Treatment 1 Intervention

Group II: Clomiphene citrate 25 mg daily for 12 weeks Experimental Treatment 1 Intervention

Clomiphene Citrate is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Clomid for:

• Infertility in women with polycystic ovary syndrome (PCOS)
• Male hypogonadism

Approved in Canada as Serophene for:

• Infertility in women with polycystic ovary syndrome (PCOS)
• Male hypogonadism

Approved in European Union as Clomiphene Citrate for:

• Infertility in women with polycystic ovary syndrome (PCOS)
• Male hypogonadism

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Twenty-five milligrams of clomiphene citrate presents positive effect on treatment of male testosterone deficiency - a prospective study. [2019]

2. China pubmed.ncbi.nlm.nih.gov

Pre-treatment estradiol does not predict testosterone response to clomiphene citrate. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Clomiphene citrate treatment for late onset hypogonadism: rise and fall. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clomiphene Citrate for the Treatment of Hypogonadism. [2019]

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

Clomiphene citrate and testosterone gel replacement therapy for male hypogonadism: efficacy and treatment cost. [2013]

6. England pubmed.ncbi.nlm.nih.gov

The safety and efficacy of clomiphene citrate in hypoandrogenic and subfertile men. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Clomiphene citrate: A potential alternative for testosterone therapy in hypogonadal males. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Oral enclomiphene citrate stimulates the endogenous production of testosterone and sperm counts in men with low testosterone: comparison with testosterone gel. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Outcomes of clomiphene citrate treatment in young hypogonadal men. [2022]

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

Clomiphene for hypogonadism complicated by polycythemia. [2020]