Hypogonadotropic Hypogonadism in Obese Young Males

• Status: Recruiting
• Trial end date: 2026-12-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sandeep Singh Dhindsa, M.D., F.A.C.E
• Treatments: Clomiphene; Enclomiphene; Testosterone; Zuclomiphene

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