Idiopathic Hypogonadotropic HypogonadismPhase 4NCT01601327
Effects of Medications in Patients With Hypogonadism
A Phase 4 study testing Testosterone enanthate (Sustanon 250 mg), Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU) and Testosteron gel (Testojel 50 mg) in people with Idiopathic Hypogonadotropic Hypogonadism, run by Gulhane School of Medicine at 2 sites in Turkey (Türkiye).
Trial summary
The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH). Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Hypogonadotropic Hypogonadism
- What is being tested?
- Testosterone enanthate (Sustanon 250 mg), Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU) and Testosteron gel (Testojel 50 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jan 2008to Mar 2012
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
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.
- Participants with iron, vitamin B12 or folate deficiency were also excluded.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gulhane School of Medicine Dep. of Endocrine and Metabolism
Ankara, 06018
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Ankara, 06018
About this study
Official title: Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience
The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Being tested
- Testosterone enanthate (Sustanon 250 mg), Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU), Testosteron gel (Testojel 50 mg)
- Keywords
- hypogonadism, treatment, testis volume
- 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.
Testosterone enanthate (Sustanon 250 mg)Drug
Twenty-eight patients were treated with testosterone enanthate (TE),
Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)Drug
twenty-five patients were treated with human chorionic gonadotropin (hCG)
Testosteron gel (Testojel 50 mg)Drug
Twenty-four patients were treated with testosterone gel (TG).
| Study group | Role | What they receive |
|---|---|---|
| hypogonadism, treatment | Other | 77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin Receives: Drug: Testosterone enanthate (Sustanon 250 mg); Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU); Drug: Testosteron gel (Testojel 50 mg) |
| Control group | No intervention | 42 healthy controls Receives: Drug: Testosterone enanthate (Sustanon 250 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Measured: 3 years
Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Measured: 3 years
Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Measured: 3 years
Secondary outcomes (3)
Effect of testosterone enanthate on testis volumes
Measured: 3 years
Effect of testosterone gel on testis volumes
Measured: 3 years
Effect of human chorionic gonadotrophin on testis volumes
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJan 2008
- Primary completionMar 2012
- Study completionMar 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 119 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, Principal investigator, Gulhane School of Medicine, Department of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601327
- Sponsor's protocol ID
- 01052012
- Status last verified
- May 2012
- First submitted
- 1 May 2012
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience
- ClinicalTrials.gov ID
- NCT01601327
- Acronym / sponsor ID
- 01052012
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Keywords
- hypogonadism, treatment, testis volume
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 May 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 aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypogonadism, treatment | Other | Drug: Testosterone enanthate (Sustanon 250 mg), Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU), Drug: Testosteron gel (Testojel 50 mg)77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin |
| Control group | No intervention | Drug: Testosterone enanthate (Sustanon 250 mg)42 healthy controls |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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 (8 listed)
- previous androgen treatment,
- history of smoking,
- presence of bilateral anorchia,
- intellectual deficiency,
- 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 |
|---|---|---|
| Testosterone enanthate (Sustanon 250 mg)Twenty-eight patients were treated with testosterone enanthate (TE), | Drug | Control group, hypogonadism, treatment |
| Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)twenty-five patients were treated with human chorionic gonadotropin (hCG) | Drug | hypogonadism, treatment |
| Testosteron gel (Testojel 50 mg)Twenty-four patients were treated with testosterone gel (TG). | Drug | hypogonadism, treatment |
Primary outcome
Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Time frame: 3 years
Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Time frame: 3 years
Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Time frame: 3 years
3 secondary outcomes
Effect of testosterone enanthate on testis volumes
Time frame: 3 years
Effect of testosterone gel on testis volumes
Time frame: 3 years
Effect of human chorionic gonadotrophin on testis volumes
Time frame: 3 years
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 May 2012.
Related trials for Idiopathic Hypogonadotropic Hypogonadism
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Kisspeptin Administration Subcutaneously to Patients With IHH
Hypogonadotropic Hypogonadism
Not yet recruitingPhase 3
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
Idiopathic Hypogonadotropic Hypogonadism
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 principal investigator
Gulhane School of Medicine, Department of Endocrinology and Metabolism
2 sites 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 enanthate (Sustanon 250 mg), Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU) and Testosteron gel (Testojel 50 mg) in people with Idiopathic Hypogonadotropic Hypogonadism, run by Gulhane School of Medicine at 2 sites 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 4 inclusion and 8 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 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured. (time frame: 3 years). 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 18 May 2012.