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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02847806
Acronym
STEROSENS
Enrollment
6
Registered
2016-07-28
Start date
2008-01-31
Completion date
2016-08-31
Last updated
2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

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.

Interventions

BIOLOGICALEstradiol (Insulin sensitivity)
BIOLOGICALTestosterone (Insulin sensitivity)

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
GIR (glucose infusion rate) during euglycemic hyperinsulinemic clampchange between baseline and after 4 weeks of treatments

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026