Idiopathic Hypogonadotropic HypogonadismNCT01758094
Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism
An observational study of Idiopathic Hypogonadotropic Hypogonadism, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism. Read more about this study
- Who is it for?
- Ages 19 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Hypogonadotropic Hypogonadism
- What is being tested?
- Sustanon 250 mg ampule (Testosterone esters)
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2008to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Patients with hypogonadotrophic hypogonadism
Who may be able to join
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Ankara, 06018
About this study
The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism.
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Being tested
- Sustanon 250 mg ampule (Testosterone esters)
- Keywords
- hypogonadism, Retinol binding globulin 4, Testosterone treatment
- Medical subject headings
- Idiopathic Hypogonadotropic Hypogonadism, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustanon 250 mg ampule (Testosterone esters)Drug
Also called No name
Drug used for treatment of hypogonadism
| Study group | Role | What they receive |
|---|---|---|
| Hypogonadotropic hypogonadism patients | Treatment naive 25 patients with idiopathic hypogonadotrophic hypogonadism Receives: Drug: Sustanon 250 mg ampule (Testosterone esters) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism
Measured: 2008-2012
Secondary outcomes (1)
Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism
Measured: 2008-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydogan Aydogdu, Gulhane School of Medicine
- Investigators
- Aydogan Aydogdu, MD, Study director, Gulhane School of Medicine, Department of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758094
- Sponsor's protocol ID
- 24122012
- Status last verified
- Jan 2013
- First submitted
- 24 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism
- ClinicalTrials.gov ID
- NCT01758094
- Acronym / sponsor ID
- 24122012
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Keywords
- hypogonadism, Retinol binding globulin 4, Testosterone treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypogonadotropic hypogonadism patients | – | Drug: Sustanon 250 mg ampule (Testosterone esters)Treatment naive 25 patients with idiopathic hypogonadotrophic hypogonadism |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with hypogonadotrophic hypogonadism
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustanon 250 mg ampule (Testosterone esters)Also: No nameDrug used for treatment of hypogonadism | Drug | Hypogonadotropic hypogonadism patients |
Primary outcome
Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism
Time frame: 2008-2012
1 secondary outcome
Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism
Time frame: 2008-2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aydogan Aydogdu, MD study director
Gulhane School of Medicine, Department of Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Hypogonadotropic Hypogonadism, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism (time frame: 2008-2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.