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Hypogonadotropic Hypogonadism in Obese Young Males

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What is being tested

Clomiphene

+ Placebo

Drug
Who is being recruted

Endocrine System Diseases

+ Gonadal Disorders

+ Hypogonadism

From 18 to 30 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: April 2019
See protocol details

Summary

Principal SponsorSandeep Singh Dhindsa, M.D., F.A.C.E
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2019

Actual date on which the first participant was enrolled.

The prevalence of obesity has increased in children over the past few decades. Approximately 20% of adolescent boys are now considered obese. It is well accepted that obese children are at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent studies have uncovered yet another undesirable effect of obesity. The testosterone levels of obese boys are only half those of lean boys at completion of puberty. Testosterone is important for muscle and bone development. Men with low testosterone are at higher risk of insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since testosterone is the major reproductive hormone, these obese boys are at risk of decreased fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter, there is a decline in testosterone levels at the rate of 2% per year for the rest of life. Thus there is a clear need to develop a deeper understanding of low testosterone in these males who are entering their peak fertility years. There are no approved treatments for this disorder. The investigators propose to conduct a randomized placebo controlled trial to evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have low testosterone concentrations. Clomiphene is a drug that increases testosterone concentrations and possibly increases sperm production. In contrast, testosterone replacement therapy decreased fertility and cannot be used in young men. Investigators will study the effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study will evaluate:- 1. testicular function: Testosterone and two proteins secreted by testis(insulin like factor 3 and inhibin B) will be measured in the blood before and after treatment with clomiphene or placebo. 2. insulin resistance: Investigators will measure insulin and glucose levels in the blood. 3. inflammation: Investigators will measure proteins that induce inflammation.

Official TitleHypogonadotropic Hypogonadism in Obese Young Males
Principal SponsorSandeep Singh Dhindsa, M.D., F.A.C.E
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesGonadal DisordersHypogonadism

Criteria

Inclusion Criteria: * Males * Age 18-30 years inclusive will be recruited. A total of 90 males will be recruited:- * 30 obese males (defined as BMI ≥30 kg/m2) with HH, * 30 obese males with normal FT concentrations and * 30 lean males (defined as BMI \<25 kg/m2) with normal FT concentrations. Exclusion Criteria: * Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months * Hematocrit \> 50% * Congestive heart failure * currently suffering from depression * type 1 diabetes * Hepatic disease (transaminase \> 3 times normal) or cirrhosis * Renal impairment (eGFR\<30 ml/min/1.73m2) * HIV or Hepatitis C positive status * Participation in any other concurrent clinical trial * currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Subjects will be randomized to receive clomiphene capsules

Group II

Placebo
Subjects will be randomized to receive placebo capsules

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Saint Louis Univeristy

St Louis, United StatesOpen Saint Louis Univeristy in Google Maps
SuspendedOne Study Center