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NCT Number: NCT01601327

Effects of Medications in Patients With Hypogonadism

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).

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Key information

Conditions

Idiopathic Hypogonadotropic Hypogonadism Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Gulhane School of Medicine Dep. of Endocrine and Metabolism, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone enanthate (Sustanon 250 mg)

Drug

Twenty-eight patients were treated with testosterone enanthate (TE),

Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)

Drug

twenty-five patients were treated with human chorionic gonadotropin (hCG)

Testosteron gel (Testojel 50 mg)

Drug

Twenty-four patients were treated with testosterone gel (TG).

Primary outcomes

  1. Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.

    Time frame: 3 years

  2. Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.

    Time frame: 3 years

  3. Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.

    Time frame: 3 years

Secondary outcomes

  1. Effect of testosterone enanthate on testis volumes

    Time frame: 3 years

  2. Effect of testosterone gel on testis volumes

    Time frame: 3 years

  3. Effect of human chorionic gonadotrophin on testis volumes

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 18, 2012
Registry last updated
May 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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