Effects of Medications in Patients With Hypogonadism

NCT ID: NCT01601327

Last Updated: 2012-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Hypogonadotropic Hypogonadism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hypogonadism, treatment

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

Group Type OTHER

Testosterone enanthate (Sustanon 250 mg)

Intervention Type DRUG

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

Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)

Intervention Type DRUG

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

Testosteron gel (Testojel 50 mg)

Intervention Type DRUG

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

Control group

42 healthy controls

Group Type NO_INTERVENTION

Testosterone enanthate (Sustanon 250 mg)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Testosterone enanthate (Sustanon 250 mg)

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

Intervention Type DRUG

Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)

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

Intervention Type DRUG

Testosteron gel (Testojel 50 mg)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gulhane School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aydogan Aydogdu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aydogan Aydogdu, MD

Role: PRINCIPAL_INVESTIGATOR

Gulhane School of Medicine, Department of Endocrinology and Metabolism

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gulhane School of Medicine Dep. of Endocrine and Metabolism

Ankara, , Turkey (Türkiye)

Site Status

Gulhane School of Medicine Dep. of Endocrinology and Metabolism

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01052012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.