Hypogonadotrophic HypogonadismPhase 4NCT01533129
The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism
A Phase 4 study testing Testogel 50 mg transdermal gel and Testosterone 250mg injection in people with Hypogonadotrophic Hypogonadism, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The study searched for answers to two questions 1. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance? 2. Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection… Read more about this study
- Who is it for?
- Ages 18 to 26 years, men only
- Conditions the study is for
- Hypogonadotrophic Hypogonadism
- What is being tested?
- Testogel 50 mg transdermal gel and Testosterone 250mg injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2008to Apr 2011
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Men
- Treatment naive
- Hypogonadotrophic hypogonadism
Who cannot join
- Previous history of androgen replacement
- Chronic metabolic disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, Non US, 06018
About this study
Official title: Phase 4 Study That Evaluates the Effects of Two Different Testosterone Replacement Regiments on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism.
The study searched for answers to two questions
- What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
- Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.
- Conditions
- Hypogonadotrophic Hypogonadism
- Being tested
- Testogel 50 mg transdermal gel, Testosterone 250mg injection
- Keywords
- Hypogonadism, Endothelial dysfunction, Inflammation, Insulin resistance, Testosterone replacement therapy
- Medical subject headings
- Hypogonadism, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testogel 50 mg transdermal gelDrug
Also called Testogel 50mg transdermal gel
50mg testosterone gel implementation on every night
Testosterone 250mg injectionDrug
Also called Sustanon 250 mg amp.
The testosterone 250mg ester IM injections performed in three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Daily testosterone transdermal gel | Active comparator | Not described Receives: Drug: Testogel 50 mg transdermal gel |
| Injectable Testosterone esters | Active comparator | Testosteron 250mg injection per 3-4 weeks for 6 months Receives: Drug: Testosterone 250mg injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The alterations in the measures for endothelial functions
The alterations in Endothelial functions are determined by measuring plazma ADMA levels, as a surrogate. ADMA measurement is pereformed by ELISA kit (Immundiagnotik, Bensheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.
Measured: 6 months
The alterations in the measures of insulin resistance
The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.
Measured: 6 months
The alterations in the measures of inflammation
The alterations in the measures of inflammation are determined by measuring Human Pentraxin-3 levels. ELISA kiti /R\&D Systems, Inc. Minneapolis, MN, ABD) (Catalog number DPTX30) with a minimal detection limit of 0.025ng/ml, intraassay CV of 3.8-4.4%, and interassay CV of 4.1-6.1% was used.
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 posted15 Feb 2012 (estimated)
- Study startAug 2008
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadotrophic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Sonmez, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533129
- Sponsor's protocol ID
- GSM-022011
- Status last verified
- Jul 2020
- First submitted
- 13 Dec 2011
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study That Evaluates the Effects of Two Different Testosterone Replacement Regiments on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism.
- ClinicalTrials.gov ID
- NCT01533129
- Acronym / sponsor ID
- GSM-022011
- Conditions
- Hypogonadotrophic Hypogonadism
- Keywords
- Hypogonadism, Endothelial dysfunction, Inflammation, Insulin resistance, Testosterone replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Apr 2011 (actual)
- First posted
- 15 Feb 2012 (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 searched for answers to two questions
- What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
- Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily testosterone transdermal gel | Active comparator | Drug: Testogel 50 mg transdermal gel |
| Injectable Testosterone esters | Active comparator | Drug: Testosterone 250mg injectionTestosteron 250mg injection per 3-4 weeks for 6 months |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men
- Treatment naive
- Hypogonadotrophic hypogonadism
Key exclusion criteria (2 listed)
- Previous history of androgen replacement
- Chronic metabolic disorders
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 |
|---|---|---|
| Testogel 50 mg transdermal gelAlso: Testogel 50mg transdermal gel50mg testosterone gel implementation on every night | Drug | Daily testosterone transdermal gel |
| Testosterone 250mg injectionAlso: Sustanon 250 mg amp.The testosterone 250mg ester IM injections performed in three weeks. | Drug | Injectable Testosterone esters |
Primary outcome
The alterations in the measures for endothelial functions
Time frame: 6 months
The alterations in Endothelial functions are determined by measuring plazma ADMA levels, as a surrogate. ADMA measurement is pereformed by ELISA kit (Immundiagnotik, Bensheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.
The alterations in the measures of insulin resistance
Time frame: 6 months
The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.
The alterations in the measures of inflammation
Time frame: 6 months
The alterations in the measures of inflammation are determined by measuring Human Pentraxin-3 levels. ELISA kiti /R\&D Systems, Inc. Minneapolis, MN, ABD) (Catalog number DPTX30) with a minimal detection limit of 0.025ng/ml, intraassay CV of 3.8-4.4%, and interassay CV of 4.1-6.1% was used.
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 22 Jul 2020.
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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 Testogel 50 mg transdermal gel and Testosterone 250mg injection in people with Hypogonadotrophic 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 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 22 Jul 2020. 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 alterations in the measures for endothelial functions (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 22 Jul 2020.