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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether clomiphene citrate (also known as Clomid or Serophene) can effectively boost low testosterone levels in men. Researchers are testing two dosing schedules: a daily dose and an every-other-day dose. Men diagnosed with low testosterone (less than 300 ng/dl) on two occasions before 10 AM may be suitable candidates. The goal is to determine which dose is most effective and safest for improving testosterone levels. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that clomiphene citrate is likely to be safe for humans?

Research shows that clomiphene citrate is generally safe for men with low testosterone. Studies have found it to be well-tolerated with few side effects, even with long-term use. One study found that clomiphene can be more effective than direct testosterone treatments for certain conditions and may reduce the risk of death. Additionally, clomiphene has demonstrated good results in both short and long-term use for boosting testosterone, with a strong safety record. Overall, evidence suggests clomiphene citrate is a safe option for increasing testosterone levels in men. ^{1 2 3 4 5}

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

Unlike the standard treatments for low testosterone, which often involve testosterone replacement therapy (TRT) delivered via injections, patches, or gels, Clomiphene Citrate offers a unique approach. This drug stimulates the body's own production of testosterone by acting on the hypothalamus and pituitary gland to increase the release of hormones that naturally boost testosterone levels. Researchers are excited about Clomiphene Citrate because it has the potential to preserve fertility, which is a significant advantage over traditional TRT that can suppress natural testosterone production and impair sperm production. Plus, the oral administration of Clomiphene Citrate is more convenient than many existing methods, making it an appealing option for many patients.

What evidence suggests that clomiphene citrate could be an effective treatment for low testosterone?

Research has shown that clomiphene citrate effectively treats men with low testosterone. In one study, 74% of patients reported feeling better after using the drug. It improves both blood levels and symptoms of low testosterone, a condition where the body doesn't produce enough of this hormone. Clomiphene citrate is also considered safe and effective for long-term use, with few side effects. This trial will evaluate two dosing regimens: one group will receive 25 mg daily, while another group will receive 50 mg every other day, both for 12 weeks. This makes it a promising option for men seeking to increase their testosterone levels. ^{1 3 5 6 7}

Who Is on the Research Team?

Jonathan Gal, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10164424/

Clomiphene citrate: A potential alternative for testosterone ... With CC treatment, 74% of the patients experienced hypogonadal symptom improvement. LH at the lower normal range before CC treatment was ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31216250/

Long-Term Safety and Efficacy of Clomiphene Citrate for ... These data demonstrate that clomiphene citrate is safe and effective with few side effects when used as long-term treatment of hypogonadism.

3. academic.oup.com academic.oup.com/jes/article/9/7/bvaf078/8124432

Reduced IGF-1 Levels Following Clomiphene Treatment for ... Clomiphene therapy can result in a significant reduction in serum IGF-1 levels in some treated hypogonadal men.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/andr.13146

Clomiphene citrate for men with hypogonadism: a ... Clomiphene citrate is an effective therapy for improving both biochemical as well as clinical symptoms of males suffering from hypogonadism.

5. cureus.com cureus.com/articles/97172-effectiveness-of-clomiphene-citrate-for-improving-sperm-concentration-a-literature-review-and-meta-analysis

Effectiveness of Clomiphene Citrate for Improving Sperm ... From data reported, the treatment with clomiphene lead to a significant improvement of sperm concentration compared with placebo or with the ...

6. academic.oup.com academic.oup.com/jes/article/5/Supplement_1/A761/6241807

Safety and Efficacy of Clomiphene Citrate in the Treatment of ... The study showed that clomiphene is more effective than testosterone to treat secondary hypogonadism. We also found decreased overall mortality and incidence ...

7. tau.amegroups.org tau.amegroups.org/article/view/129106/html

Safety and efficacy of enclomiphene and clomiphene for ... Our findings demonstrate that enclomiphene provides improvement in testosterone levels with a lower rate of documented adverse events.