Hypogonadotropic Hypogonadism in Obese Young Males
Primary Purpose
Hypogonadism, Hypogonadotropic
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clomiphene
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism, Hypogonadotropic
Eligibility 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
Sites / Locations
- Saint Louis Univeristy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
No Intervention
No Intervention
Arm Label
Obese males with hypogonadism-active
Obese males with hypogonadism-placebo
Obese males with normal testosterone
lean males with normal testosterone
Arm Description
Subjects will be randomized to receive clomiphene capsules
Subjects will be randomized to receive placebo capsules
comparison group
comparison group
Outcomes
Primary Outcome Measures
Serum Free Testosterone
after clomiphene or placebo treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03245827
First Posted
August 3, 2017
Last Updated
June 28, 2022
Sponsor
Sandeep Singh Dhindsa, M.D., F.A.C.E
1. Study Identification
Unique Protocol Identification Number
NCT03245827
Brief Title
Hypogonadotropic Hypogonadism in Obese Young Males
Official Title
Hypogonadotropic Hypogonadism in Obese Young Males
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
not enough recruitment
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sandeep Singh Dhindsa, M.D., F.A.C.E
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 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:-
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.
insulin resistance: Investigators will measure insulin and glucose levels in the blood.
inflammation: Investigators will measure proteins that induce inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Hypogonadotropic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese males with hypogonadism-active
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to receive clomiphene capsules
Arm Title
Obese males with hypogonadism-placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to receive placebo capsules
Arm Title
Obese males with normal testosterone
Arm Type
No Intervention
Arm Description
comparison group
Arm Title
lean males with normal testosterone
Arm Type
No Intervention
Arm Description
comparison group
Intervention Type
Drug
Intervention Name(s)
Clomiphene
Other Intervention Name(s)
active
Intervention Description
clomiphene capsule 25mg twice a week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsule 25mg twice a week
Primary Outcome Measure Information:
Title
Serum Free Testosterone
Description
after clomiphene or placebo treatment
Time Frame
12 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
males
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sandeep dhindsa, md
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis Univeristy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hypogonadotropic Hypogonadism in Obese Young Males
We'll reach out to this number within 24 hrs