Effects of Medications in Patients With Hypogonadism

Study Overview
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Brief Summary
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The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).

Official Title
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Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience

Conditions
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Idiopathic Hypogonadotropic Hypogonadism

Intervention / Treatment
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* Drug: Testosterone enanthate (Sustanon 250 mg)
* Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)
* Drug: Testosteron gel (Testojel 50 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hypogonadotropic hypogonadism decreased serum testosterone concentration below the normal range (serum T < 300ng/dL), FSH and LH levels within or below the normal range, absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, normal smell test and normal karyotypes Exclusion Criteria: previous androgen treatment, history of smoking, presence of bilateral anorchia, intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia, medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded. Participants with iron, vitamin B12 or folate deficiency were also excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hypogonadism, treatment<br>77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin | Drug: Testosterone enanthate (Sustanon 250 mg)<br>* Twenty-eight patients were treated with testosterone enanthate (TE),<br>Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)<br>* twenty-five patients were treated with human chorionic gonadotropin (hCG)<br>Drug: Testosteron gel (Testojel 50 mg)<br>* Twenty-four patients were treated with testosterone gel (TG).<br>|
| No Intervention: Control group<br>42 healthy controls | Drug: Testosterone enanthate (Sustanon 250 mg)<br>* Twenty-eight patients were treated with testosterone enanthate (TE),<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured. |  | 3 years | 
| Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured. |  | 3 years | 
| Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of testosterone enanthate on testis volumes |  | 3 years | 
| Effect of testosterone gel on testis volumes |  | 3 years | 
| Effect of human chorionic gonadotrophin on testis volumes |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypogonadism, treatment, testis volume