Effects of Medications in Patients With Hypogonadism

May 17, 2012 updated by: Aydogan Aydogdu, Gulhane School of Medicine

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06018
        • Gulhane School of Medicine Dep. of Endocrine and Metabolism
      • Ankara, Turkey, 06018
        • Gulhane School of Medicine Dep. of Endocrinology and Metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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),

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane School of Medicine

Investigators

  • Principal Investigator: Aydogan Aydogdu, MD, Gulhane School of Medicine, Department of Endocrinology and Metabolism

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Estimate)

May 18, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01052012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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