HypogonadismPhase 4NCT01160341
Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism
A Phase 4 study testing Testosteron 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. Is hypogonadism a cause for the metabolic syndrome ? 2. What is the effect of testosterone replacement on the metabolic parameters ? Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosteron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2009to Jan 2010
- 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 26 years
- Men only
- Healthy volunteers accepted
- 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 About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome
The study is designed to answer the following questions:
- Is hypogonadism a cause for the metabolic syndrome ?
- What is the effect of testosterone replacement on the metabolic parameters ?
Read the detailed description
This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2002-2009.
- Conditions
- Hypogonadism
- Being tested
- Testosteron
- Keywords
- Metabolic syndrome, Hypogonadism, Testosterone
- Medical subject headings
- Hypogonadism, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteronDrug
Also called Sustanon 250mg
Testosteron 250mg injection per 3-4 weeks for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Testosteron, secondary hypogonadism | Experimental | Not described Receives: Drug: Testosteron |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160341
- Sponsor's protocol ID
- GSM-072010
- Status last verified
- Jan 2010
- First submitted
- 9 Jul 2010
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul;60(7):762-9. doi: 10.1111/j.1742-1241.2006.00992.x.
PubMed 16846397Araujo AB, O'Donnell AB, Brambilla DJ, Simpson WB, Longcope C, Matsumoto AM, McKinlay JB. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 2004 Dec;89(12):5920-6. doi: 10.1210/jc.2003-031719.
PubMed 15579737Saad F, Gooren LJ, Haider A, Yassin A. A dose-response study of testosterone on sexual dysfunction and features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate. J Androl. 2008 Jan-Feb;29(1):102-5. doi: 10.2164/jandrol.107.002774. Epub 2007 Oct 3.
PubMed 17916569Koesling D, Schultz G, Bohme E. Sequence homologies between guanylyl cyclases and structural analogies to other signal-transducing proteins. FEBS Lett. 1991 Mar 25;280(2):301-6. doi: 10.1016/0014-5793(91)80317-v.
PubMed 1672855
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01160341
- Acronym / sponsor ID
- GSM-072010
- Conditions
- Hypogonadism
- Keywords
- Metabolic syndrome, Hypogonadism, Testosterone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Jul 2010 (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:
- Is hypogonadism a cause for the metabolic syndrome ?
- What is the effect of testosterone replacement on the metabolic parameters ?
Detailed description
This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2002-2009.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosteron, secondary hypogonadism | Experimental | Drug: Testosteron |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- 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 |
|---|---|---|
| TestosteronAlso: Sustanon 250mgTestosteron 250mg injection per 3-4 weeks for 6 months | Drug | Testosteron, secondary hypogonadism |
Primary outcome
Not reported in the source record.
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 12 Jul 2010.
- Background: PubMed 16846397Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul;60(7):762-9. doi: 10.1111/j.1742-1241.2006.00992.x.
- Background: PubMed 15579737Araujo AB, O'Donnell AB, Brambilla DJ, Simpson WB, Longcope C, Matsumoto AM, McKinlay JB. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 2004 Dec;89(12):5920-6. doi: 10.1210/jc.2003-031719.
- Background: PubMed 17916569Saad F, Gooren LJ, Haider A, Yassin A. A dose-response study of testosterone on sexual dysfunction and features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate. J Androl. 2008 Jan-Feb;29(1):102-5. doi: 10.2164/jandrol.107.002774. Epub 2007 Oct 3.
- Background: PubMed 1672855Koesling D, Schultz G, Bohme E. Sequence homologies between guanylyl cyclases and structural analogies to other signal-transducing proteins. FEBS Lett. 1991 Mar 25;280(2):301-6. doi: 10.1016/0014-5793(91)80317-v.
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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 Testosteron 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 12 Jul 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01160341, which also lists 4 linked publications.
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 12 Jul 2010.