NCT01601327

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

4.2 years

First QC Date

May 1, 2012

Last Update Submit

May 17, 2012

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Keywords

hypogonadismtreatmenttestis volume

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

hypogonadism, treatment

OTHER

77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin

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

Control group

NO INTERVENTION

42 healthy controls

Drug: Testosterone enanthate (Sustanon 250 mg)

Interventions

Testosterone enanthate (Sustanon 250 mg)DRUG

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

Control grouphypogonadism, treatment
Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)DRUG

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

hypogonadism, treatment
Testosteron gel (Testojel 50 mg)DRUG

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

hypogonadism, treatment

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gulhane School of Medicine Dep. of Endocrine and Metabolism

Ankara, 06018, Turkey (Türkiye)

Location

Gulhane School of Medicine Dep. of Endocrinology and Metabolism

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Idiopathic Hypogonadotropic HypogonadismHypogonadism

Interventions

testosterone enanthateTestosteroneChorionic Gonadotropin

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGonadotropinsPeptide HormonesPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Aydogan Aydogdu, MD

    Gulhane School of Medicine, Department of Endocrinology and Metabolism

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 18, 2012

Study Start

January 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

TU(2)