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

C

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

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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