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NCT02154477 · ClinicalTrials.gov registry record · Phase 1

Effect of Intranasal Insulin on LH Concentrations in Man

A Phase 1 study of Hypogonadotropic Hypogonadism, sponsored by Texas Tech University Health Sciences Center.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
1
Study location

NCT02154477 is a Phase 1 study of Hypogonadotropic Hypogonadism that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 14 participants, below the 124-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02154477, a Phase 1 study of Hypogonadotropic Hypogonadism, has completed, sponsored by Texas Tech University Health Sciences Center.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
1
Study location

Study Summary

Over the last few years, studies have shown that men with type 2 diabetes sometimes develop a condition called hypogonadotrophic hypogonadism (HH). People with this condition produce little or no sex hormones. Obesity and metabolic syndrome are also associated with HH. Research suggests that insulin in the brain may benefit the glands that release these hormones. During this study, subjects will spray a small amount of insulin into their nose.This will increase insulin concentrations in the brain. The purpose of this study is to find out the effect of one dose of intranasal insulin on release of LH (a sex hormone) in obese diabetic men with HH.

Interventions

  • DRUG intranasal insulin
  • DRUG placebo (intranasal saline)

Study Locations (1)

Texas

  • TTTUHSC-Permian Basin - Odessa

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2014-12
Est. Completion 2017-12
Phase Phase 1

What the Registry Record Tells You About NCT02154477

The ClinicalTrials.gov registry entry for NCT02154477 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 124-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (89% lower). The listed sponsor is Texas Tech University Health Sciences Center, which has 76 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypogonadotropic Hypogonadism appearing as the primary indexed condition, and to 2 interventions - of which intranasal insulin is the first listed.

NCT02154477 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT02154477 about?

NCT02154477 is a clinical study titled "Effect of Intranasal Insulin on LH Concentrations in Man". Over the last few years, studies have shown that men with type 2 diabetes sometimes develop a condition called hypogonadotrophic hypogonadism (HH). People with this condition produce little or no sex hormones. Obesity and metabolic syndrome are also associated with HH. Research suggests that insulin...

What is the current status of trial NCT02154477?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2014-12. Estimated completion is 2017-12.

What conditions does trial NCT02154477 study?

This clinical trial studies the following conditions: Hypogonadotropic Hypogonadism.

What interventions are being tested in trial NCT02154477?

The interventions under investigation include: intranasal insulin (DRUG), placebo (intranasal saline) (DRUG).

Who is sponsoring clinical trial NCT02154477?

This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02154477 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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