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

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Estradiol (Insulin sensitivity)
Testosterone (Insulin sensitivity)
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Estradiol

Testosterone

Testosterone + Estradiol

Arm Description

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

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

Testosterone + Estradiol During 4 weeks

Outcomes

Primary Outcome Measures

GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp

Secondary Outcome Measures

Full Information

First Posted
August 13, 2015
Last Updated
August 16, 2018
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02847806
Brief Title
Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
Acronym
STEROSENS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estradiol
Arm Type
Experimental
Arm Description
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
Arm Title
Testosterone
Arm Type
Experimental
Arm Description
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
Arm Title
Testosterone + Estradiol
Arm Type
Experimental
Arm Description
Testosterone + Estradiol During 4 weeks
Intervention Type
Biological
Intervention Name(s)
Estradiol (Insulin sensitivity)
Intervention Type
Biological
Intervention Name(s)
Testosterone (Insulin sensitivity)
Primary Outcome Measure Information:
Title
GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp
Time Frame
change between baseline and after 4 weeks of treatments

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypogonadism hypogonadotropic or hypergonadotropic Man aged 18-60 years BMI between 18 and 27. Exclusion Criteria: 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
Facility Information:
Facility Name
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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