HypogonadismPhase 4NCT02111473
The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
A Phase 4 study testing Testosterone in people with Hypogonadism, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The study is designed to answer the following questions: 1) What is the effect of testosteron replacement treatment on the endothelial dysfunction. 2/ What is the effect of testosteron replacement on the bone mineral metabolism. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2009to Apr 2014
- Phase
- Phase 4
- 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 18 to 28 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men
- Congenital hypogonadism
- Treatment Naive
Who cannot join
- Previous history of androgen replacement
- Hypertension
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
The study is designed to answer the following questions:
- What is the effect of testosteron replacement treatment on the endothelial dysfunction.
2/ What is the effect of testosteron replacement on the bone mineral metabolism.
Read the detailed description
this is an interventional study which is examine the effect of testosteron replacement treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic hypogonadal patients.
- Conditions
- Hypogonadism
- Being tested
- Testosterone
- Keywords
- endothelial dysfunction, bone mineral metabolism, testosteron replacement treatment
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called sustanon 250 mg
Testosterone 250 mg injection per 3-4 weeks for 6 months
| Study group | Role | What they receive |
|---|---|---|
| testosterone | Other | testosterone 250 mg injection per 3-4 weeks for 6 months Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.
Plasma FGF-23 levels were determined by ELISA, (Human Intact FGF-23 ELISA Kit, Inc., San Clement, CA, USA).
Measured: 6 months
the effect of testosteron replacement treatment on the asymmetric dimethylarginine.
Plasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany)
Measured: 6 months
the effect of testosteron replacement treatment on the vitamin D levels.
Plasma 25-OH vitamin D3 levels were measured by Immuchrom kits (Hessen, Germany) using isocratic HPLC method with UV detector in Prominence HPLC system.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, cem haymana, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111473
- Sponsor's protocol ID
- GSM-032014
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
- ClinicalTrials.gov ID
- NCT02111473
- Acronym / sponsor ID
- GSM-032014
- Conditions
- Hypogonadism
- Keywords
- endothelial dysfunction, bone mineral metabolism, testosteron replacement treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Apr 2014 (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 study is designed to answer the following questions:
- What is the effect of testosteron replacement treatment on the endothelial dysfunction.
2/ What is the effect of testosteron replacement on the bone mineral metabolism.
Detailed description
this is an interventional study which is examine the effect of testosteron replacement treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic hypogonadal patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| testosterone | Other | Drug: Testosteronetestosterone 250 mg injection per 3-4 weeks for 6 months |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men
- Congenital hypogonadism
- Treatment Naive
Key exclusion criteria (3 listed)
- Previous history of androgen replacement
- Hypertension
- Diabetes mellitus
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 |
|---|---|---|
| TestosteroneAlso: sustanon 250 mgTestosterone 250 mg injection per 3-4 weeks for 6 months | Drug | testosterone |
Primary outcome
the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.
Time frame: 6 months
Plasma FGF-23 levels were determined by ELISA, (Human Intact FGF-23 ELISA Kit, Inc., San Clement, CA, USA).
the effect of testosteron replacement treatment on the asymmetric dimethylarginine.
Time frame: 6 months
Plasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany)
the effect of testosteron replacement treatment on the vitamin D levels.
Time frame: 6 months.
Plasma 25-OH vitamin D3 levels were measured by Immuchrom kits (Hessen, Germany) using isocratic HPLC method with UV detector in Prominence HPLC system.
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 11 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone in people with 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 3 inclusion and 3 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 11 Apr 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23. (time frame: 6 months). The study lists 3 primary outcomes in all. 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 11 Apr 2014.