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Hypogonadotropic Hypogonadism in Obese Young Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03245827
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : October 30, 2020
Information provided by (Responsible Party):
Sandeep Singh Dhindsa, M.D., F.A.C.E, St. Louis University

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.

Condition or disease Intervention/treatment Phase
Hypogonadism, Hypogonadotropic Drug: Clomiphene Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Hypogonadotropic Hypogonadism in Obese Young Males
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Obese males with hypogonadism-active
Subjects will be randomized to receive clomiphene capsules
Drug: Clomiphene
clomiphene capsule 25mg twice a week
Other Name: active

Placebo Comparator: Obese males with hypogonadism-placebo
Subjects will be randomized to receive placebo capsules
Drug: Placebo
placebo capsule 25mg twice a week

No Intervention: Obese males with normal testosterone
comparison group
No Intervention: lean males with normal testosterone
comparison group

Primary Outcome Measures :
  1. change in serum testosterone [ Time Frame: 12 weeks ]
    after clomiphene or placebo treatment

Secondary Outcome Measures :
  1. change in insulin like factor 3 [ Time Frame: 12 weeks ]
    after clomiphene or placebo treatment

  2. change in inhibin B [ Time Frame: 12 weeks ]
    after clomiphene or placebo treatment

  3. change in insulin resistance (HOMA-IR) [ Time Frame: 12 weeks ]
    after clomiphene or placebo treatment

  4. change in nflammation [ Time Frame: 12 weeks ]
    after clomiphene or placebo treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   males
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03245827

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Contact: Sandeep S dhindsa, MD 3149774911

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United States, Missouri
Saint Louis Univeristy Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Bobby Campbell         
Sponsors and Collaborators
Sandeep Singh Dhindsa, M.D., F.A.C.E
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Principal Investigator: sandeep dhindsa, md St. Louis University
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Responsible Party: Sandeep Singh Dhindsa, M.D., F.A.C.E, Professor, St. Louis University Identifier: NCT03245827    
Other Study ID Numbers: 28389
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators