Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
NCT ID: NCT02847806
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
6 participants
INTERVENTIONAL
2008-01-31
2016-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Estradiol
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
Estradiol (Insulin sensitivity)
Testosterone
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 (Insulin sensitivity)
Testosterone + Estradiol
Testosterone + Estradiol During 4 weeks
Estradiol (Insulin sensitivity)
Testosterone (Insulin sensitivity)
Interventions
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Estradiol (Insulin sensitivity)
Testosterone (Insulin sensitivity)
Eligibility Criteria
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Inclusion Criteria
* Man aged 18-60 years
* BMI between 18 and 27.
Exclusion Criteria
* Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...)
* Diabetes
* Obesity diffuse or android
* Hemochromatosis
* osteoporosis
* chronic diseases
* neoplasia
* High blood pressure
18 Years
60 Years
MALE
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Caen, , France
Countries
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Other Identifiers
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07-034
Identifier Type: -
Identifier Source: org_study_id
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