Effects of Medications in Patients With Hypogonadism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aydogan Aydogdu, Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01601327
First received: May 1, 2012
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention Phase
Idiopathic Hypogonadotropic Hypogonadism
Drug: Testosterone enanthate (Sustanon 250 mg)
Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)
Drug: Testosteron gel (Testojel 50 mg)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of testosterone enanthate on testis volumes [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Effect of testosterone gel on testis volumes [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Effect of human chorionic gonadotrophin on testis volumes [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 119
Study Start Date: January 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
hypogonadism, treatment
77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin
Drug: Testosterone enanthate (Sustanon 250 mg)
Twenty-eight patients were treated with testosterone enanthate (TE),
Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)
twenty-five patients were treated with human chorionic gonadotropin (hCG)
Drug: Testosteron gel (Testojel 50 mg)
Twenty-four patients were treated with testosterone gel (TG).
No Intervention: Control group
42 healthy controls
Drug: Testosterone enanthate (Sustanon 250 mg)
Twenty-eight patients were treated with testosterone enanthate (TE),

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01601327

Locations
Turkey
Gulhane School of Medicine Dep. of Endocrine and Metabolism
Ankara, Turkey, 06018
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
Principal Investigator: Aydogan Aydogdu, MD Gulhane School of Medicine, Department of Endocrinology and Metabolism
  More Information

No publications provided

Responsible Party: Aydogan Aydogdu, Principal Investigator, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01601327     History of Changes
Other Study ID Numbers: 01052012
Study First Received: May 1, 2012
Last Updated: May 17, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Gulhane School of Medicine:
hypogonadism
treatment
testis volume

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Chorionic Gonadotropin
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014