Status:
TERMINATED
Hypogonadotropic Hypogonadism in Obese Young Males
Lead Sponsor:
Sandeep Singh Dhindsa, M.D., F.A.C.E
Conditions:
Hypogonadism, Hypogonadotropic
Eligibility:
MALE
18-30 years
Phase:
PHASE2
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03245827
Start Date
April 1 2019
End Date
October 29 2021
Last Update
June 29 2022
Active Locations (1)
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1
Saint Louis Univeristy
St Louis, Missouri, United States, 63104