NCT03245827

Hypogonadotropic Hypogonadism in Obese Young Males

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sandeep Singh Dhindsa, M.D., F.A.C.E · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

Obesity can lead to low testosterone concentrations in young men. This study will study the effects of low testosterone in those men and the result of treating them with clomiphene.

Detailed description

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.

Conditions

• Hypogonadism, Hypogonadotropic

Interventions

Type	Name	Description
DRUG	Clomiphene	clomiphene capsule 25mg twice a week
DRUG	Placebo	placebo capsule 25mg twice a week

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2017-08-10
• Last updated: 2022-06-29
• Results posted: 2022-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study