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

Hypogonadism Clinical Trial

— STEROSENS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847806
• Other study ID #: 07-034
• Status: Completed
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Biological:
• Estradiol (Insulin sensitivity)

• Testosterone (Insulin sensitivity)

Locations

Country	Name	City	State
France	Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp		change between baseline and after 4 weeks of treatments