Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man

NCT02847806 | Completed Phase 3

• 1 other identifier: 07-034
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism. Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

• GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp

  change between baseline and after 4 weeks of treatments

Study Arms (3)

Estradiol

EXPERIMENTAL

dosage used in the study: 1 patch / 3-4 days dosed at 25, 37.5 or 50 mg / 24h titration according to the plasma level, with the objective of a physiological level of estradiol (25-40 pg / ml ) - During 4 weeks

Biological: Estradiol (Insulin sensitivity)

Testosterone

EXPERIMENTAL

dosage used : from 25 to 75 mg / day of testosterone (ie 2.5 to 7.5 g / day transdermal gel) according to the plasma level, with the goal of a physiological level of testosterone (5-8 ng / ml) - During 4 weeks

Biological: Testosterone (Insulin sensitivity)

Testosterone + Estradiol

EXPERIMENTAL

Testosterone + Estradiol During 4 weeks

Biological: Estradiol (Insulin sensitivity); Biological: Testosterone (Insulin sensitivity)

Interventions

Estradiol (Insulin sensitivity) BIOLOGICAL

Estradiol; Testosterone + Estradiol

Testosterone (Insulin sensitivity) BIOLOGICAL

Testosterone; Testosterone + Estradiol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hypogonadism hypogonadotropic or hypergonadotropic
• Man aged 18-60 years
• BMI between 18 and 27.

You may not qualify if:

• Other ante-pituitary deficiency
• Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...)
• Diabetes
• Obesity diffuse or android
• Hemochromatosis
• osteoporosis
• chronic diseases
• neoplasia
• High blood pressure

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen

Caen, 14000, France

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Estradiol; Insulin; Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Androstenols; Androstenes; Androstanes; Testosterone Congeners

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: July 28, 2016
• Study Start: January 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 17, 2018

Record last verified: 2016-07

Locations

FR (1)