Secondary HypogonadismPhase 4NCT01454011
The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups
A Phase 4 study testing Testosteron 250mg injection and Testosterone 50mg transdermal application in people with Secondary 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 there any difference between the compositions of the HDL cholesterol subpopulations of patients with hypogonadism and the healthy controls. 2. What is the effect of testosterone replacement therapy on the distributions of HDL subgroups. 3. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Secondary Hypogonadism
- What is being tested?
- Testosteron 250mg injection and Testosterone 50mg transdermal application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2008to Feb 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Congenital hypogonadotrophic hypogonadism,
- Male sex
Who cannot join
- Previous history of androgen replacement,
- any chronic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatment on HDL Subgroups.
The study is designed to answer the following questions:
- Is there any difference between the compositions of the HDL cholesterol subpopulations of patients with hypogonadism and the healthy controls.
- What is the effect of testosterone replacement therapy on the distributions of HDL subgroups.
- Is there any difference between the effects of the two different testosteron replacement regiments
Read the detailed description
This study has two designs:
- The case control design to search for the difference between the HDL subgroups and the other metabolic parameters between the healthy subjects and the patients with hypogonadism
- The follow-up study to search for the effects of two different testosterone replacement regiments.
- Conditions
- Secondary Hypogonadism
- Being tested
- Testosteron 250mg injection, Testosterone 50mg transdermal application
- Keywords
- hypogonadism, testosterone, HDL cholesterol subgroups, hsCRP, HOMA-IR
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosteron 250mg injectionDrug
Also called Sustanon 250 mg ampule
The combination of 4 different testosterone esthers (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate) injected in 3 weeks intervals.
Testosterone 50mg transdermal applicationDrug
Also called Testogel 50mg transdermal gel
Application of testosterone 50mg transdermal gel in every night
| Study group | Role | What they receive |
|---|---|---|
| Testosterone 250mg injection, | Active comparator | Not described Receives: Drug: Testosteron 250mg injection |
| Testosterone transdermal application | Active comparator | Not described Receives: Drug: Testosterone 50mg transdermal application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the HDL cholesterol levels and the HDL subgroups
The HDL subfractions were measured by polyethylene glycol (PEG) precipitation technique. Two different reagents were prepared in different PEG concentrations and pH values. The supernatant of the solution precipitated with reagent A contained total HDL cholesterol while the supernatant of the solution precipitated with reagent B, contained only the HDL3 subclass. The cholesterol was then quantified by enzymatic with CHOD-PAP reagent (Olympus Diagnostics GmbH, Hamburg, Germany). HDL2 cholesterol was measured by calculating the difference between total HDL and the HDL3 subclass.
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 posted18 Oct 2011 (estimated)
- Study startSep 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary 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
- 140 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
- NCT01454011
- Sponsor's protocol ID
- GSM-012011
- Status last verified
- Oct 2011
- First submitted
- 12 Oct 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatment on HDL Subgroups.
- ClinicalTrials.gov ID
- NCT01454011
- Acronym / sponsor ID
- GSM-012011
- Conditions
- Secondary Hypogonadism
- Keywords
- hypogonadism, testosterone, HDL cholesterol subgroups, hsCRP, HOMA-IR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 18 Oct 2011 (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 there any difference between the compositions of the HDL cholesterol subpopulations of patients with hypogonadism and the healthy controls.
- What is the effect of testosterone replacement therapy on the distributions of HDL subgroups.
- Is there any difference between the effects of the two different testosteron replacement regiments
Detailed description
This study has two designs:
- The case control design to search for the difference between the HDL subgroups and the other metabolic parameters between the healthy subjects and the patients with hypogonadism
- The follow-up study to search for the effects of two different testosterone replacement regiments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone 250mg injection, | Active comparator | Drug: Testosteron 250mg injection |
| Testosterone transdermal application | Active comparator | Drug: Testosterone 50mg transdermal application |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Congenital hypogonadotrophic hypogonadism,
- Male sex
Key exclusion criteria (2 listed)
- Previous history of androgen replacement,
- any chronic disorder
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 |
|---|---|---|
| Testosteron 250mg injectionAlso: Sustanon 250 mg ampuleThe combination of 4 different testosterone esthers (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate) injected in 3 weeks intervals. | Drug | Testosterone 250mg injection, |
| Testosterone 50mg transdermal applicationAlso: Testogel 50mg transdermal gelApplication of testosterone 50mg transdermal gel in every night | Drug | Testosterone transdermal application |
Primary outcome
Changes in the HDL cholesterol levels and the HDL subgroups
Time frame: 6 months
The HDL subfractions were measured by polyethylene glycol (PEG) precipitation technique. Two different reagents were prepared in different PEG concentrations and pH values. The supernatant of the solution precipitated with reagent A contained total HDL cholesterol while the supernatant of the solution precipitated with reagent B, contained only the HDL3 subclass. The cholesterol was then quantified by enzymatic with CHOD-PAP reagent (Olympus Diagnostics GmbH, Hamburg, Germany). HDL2 cholesterol was measured by calculating the difference between total HDL and the HDL3 subclass.
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 18 Oct 2011.
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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 250mg injection and Testosterone 50mg transdermal application in people with Secondary 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 2 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 18 Oct 2011. 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?
Changes in the HDL cholesterol levels and the HDL subgroups (time frame: 6 months). 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 18 Oct 2011.