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

Caen University Hospital

Status and phase: Completed; Phase 3

Conditions: Hypogonadism

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02847806

07-034

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Estradiol

Experimental group

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

Treatment:

Biological: Estradiol (Insulin sensitivity)

Testosterone

Experimental group

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

Treatment:

Biological: Testosterone (Insulin sensitivity)

Testosterone + Estradiol

Experimental group

Description:

Testosterone + Estradiol During 4 weeks

Treatment:

Biological: Testosterone (Insulin sensitivity)

Biological: Estradiol (Insulin sensitivity)