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Selective Estrogen Receptor Modulator

Clomiphene Citrate 25mg for Low Testosterone

Phase 2
Recruiting
Led By Caroline Kang, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male, 21-45 years of age
Serum testosterone concentration < 300 ng/dl measured on two separate occasions (separated by at least one week), with collection prior to 10AM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.
Awards & highlights

Study Summary

This trial is testing whether clomiphene citrate can raise testosterone levels in men with low testosterone.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Clomiphene Citrate may cause side effects such as vision changes, mood swings, pain in the testes, flushing, nausea, vomiting, headache. It's important for participants to report any discomforts they experience during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged between 21 and 45.
Select...
My testosterone levels are below 300 ng/dl, confirmed by two tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in serum testosterone
Secondary outcome measures
Change in FSH levels
Body Weight Changes
Change in estradiol levels

Trial Design

2Treatment groups
Experimental Treatment
Group I: Clomiphene citrate 50 mg every other day for 12 weeksExperimental Treatment1 Intervention
Group II: Clomiphene citrate 25 mg daily for 12 weeksExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clomiphene Citrate 25mg
2015
Completed Phase 2
~30
Clomiphene Citrate 50mg
2021
Completed Phase 4
~430

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,053 Previous Clinical Trials
1,330,497 Total Patients Enrolled
Caroline Kang, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
70 Total Patients Enrolled
Jonathan Gal, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
170 Total Patients Enrolled

Media Library

Clomiphene Citrate (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05096169 — Phase 2
Low Testosterone Research Study Groups: Clomiphene citrate 25 mg daily for 12 weeks, Clomiphene citrate 50 mg every other day for 12 weeks
Low Testosterone Clinical Trial 2023: Clomiphene Citrate Highlights & Side Effects. Trial Name: NCT05096169 — Phase 2
Clomiphene Citrate (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05096169 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this clinical trial limited to persons under a certain age?

"Individuals aged 21 to 45 are eligible for participation in this trial."

Answered by AI

Does this research endeavor currently need new participants to join?

"As per clinicaltrials.gov, this examination is in the process of recruiting participants and was made available on May 1st 2022 with its most recent update being recorded on May 19th of that year."

Answered by AI

What criteria must be satisfied to participate in this experiment?

"This study is currently seeking 40 males between the ages of 21 and 45 who exhibit signs of testosterone deficiency. Criteria for eligibility includes being male, as well as falling in the specified age range."

Answered by AI

How many participants are anticipated to join this clinical investigation?

"Affirmative. As per the information posted on clinicaltrials.gov, this healthcare research is presently searching for participants. This trial was initially published on May 1st 2022 and has been edited as recently as May 19th 2022. The study requires 40 patients to be enlisted from one center of care."

Answered by AI

Is Clomiphene Citrate 25mg a safe dosage for human consumption?

"As a Phase 2 trial, data collected thus far has demonstrated some safety of Clomiphene Citrate 25mg and consequently it received an assessment score of 2."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New Jersey
South Carolina
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
2
What site did they apply to?
Weill Cornell Medicine

Why did patients apply to this trial?

I am using 1.
PatientReceived 2+ prior treatments
Recent research and studies
~11 spots leftby Jan 2025