Hypogonadotropic Hypogonadism in Obese Young Males

NCT03245827 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 28389
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism, Hypogonadotropic

Outcome Measures

Primary Outcomes (1)

• Serum Free Testosterone

  after clomiphene or placebo treatment

  12 weeks

Study Arms (4)

Obese males with hypogonadism-active

ACTIVE COMPARATOR

Subjects will be randomized to receive clomiphene capsules

Drug: Clomiphene

Obese males with hypogonadism-placebo

PLACEBO COMPARATOR

Subjects will be randomized to receive placebo capsules

Drug: Placebo

Obese males with normal testosterone

NO INTERVENTION

comparison group

lean males with normal testosterone

NO INTERVENTION

comparison group

Interventions

Clomiphene DRUG

clomiphene capsule 25mg twice a week

Also known as: active

Obese males with hypogonadism-active

Placebo DRUG

placebo capsule 25mg twice a week

Obese males with hypogonadism-placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males
• Age 18-30 years inclusive will be recruited.
• A total of 90 males will be recruited:-
• obese males (defined as BMI ≥30 kg/m2) with HH,
• obese males with normal FT concentrations and
• 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

Sponsors & Collaborators

• Sandeep Singh Dhindsa, M.D., F.A.C.E: lead

Study Sites (1)

Saint Louis Univeristy

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Clomiphene; Exercise

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Sandeep Dhindsa
• Organization: Saint Louis University

sandeep.dhindsa@health.slu.edu

716-977-4911

Study Officials

• sandeep dhindsa, md

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 10, 2017
• Study Start: April 1, 2019
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: June 29, 2022
• Results First Posted: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)