Hypogonadotropic Hypogonadism in Obese Young Males

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hypogonadism, Hypogonadotropic

In brief

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.

Key facts

Study ID

NCT03245827

Run by

Sandeep Singh Dhindsa, M.D., F.A.C.E

People needed

9

Starts

2019-04-01

Expected to finish

2021-10-29

Last updated by the study team

2022-06-29

Who can join

Age: 18 and older, up to 30. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Saint Louis Univeristy — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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