Idiopathic Hypogonadotropic HypogonadismNCT02728440
Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism
An observational study of Idiopathic Hypogonadotropic Hypogonadism, run by Gulhane School of Medicine.
Trial summary
Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism Read more about this study
- Who is it for?
- Ages 22 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Hypogonadotropic Hypogonadism
- What is being tested?
- human chorionic gonadotropin, human menopausal gonadotropin
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Dec 2012
- Phase
- Observational
- 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 22 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Patients with Idiopathic Hypogonadotropic Hypogonadism and healthy control group
Who may be able to join
- Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -
Who cannot join
- diabetes mellitus, arterial hypertension other hormone deficiencies
- -
About this study
Official title: Lipid Profile and Oxidative Stress Parameters of Patients With Idiopathic Hypogonadotropic Hypogonadism and the Change of These Parameters With Gonadotropin Replacement Therapy
Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism
Read the detailed description
30 male patients diagnosed with IHH and a control group of 20 healthy cases with similar age and BMI were included in the study. The levels of advanced oxidation protein products (AOPP), thiol, malondialdehyde (MDA), nitric oxide (NO) and 8-hydroxydeoxyguanosine (8-OHdG) and the levels of triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-K), low density lipoprotein (LDL-K), Apolipoprotein A1 (ApoA1) and Apolipoprotein B100 (ApoB100) were measured before and after gonadotrophin therapy.
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Being tested
- human chorionic gonadotropin, human menopausal gonadotropin
- Medical subject headings
- Idiopathic Hypogonadotropic Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human chorionic gonadotropin, human menopausal gonadotropinDrug
Also called Pregnyl ® Organon hCG 1500 IU, Merional ® ARIS 75 IU
drug for the treatment of male hypogonadism
| Study group | Role | What they receive |
|---|---|---|
| Hypogonadotropic hypogonadism patients | 30 patients with idiopathic hypogonadotrophic hypogonadism Receives: Drug: human chorionic gonadotropin, human menopausal gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative stress after hCG and HMG treatment
Measured: 2010-2012
HDL levels after hCG treatment
Measured: 2010-2012
total cholesterole levels after hCG treatment
Measured: 2010-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startMay 2010
- Primary completionDec 2012
- Study completionDec 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728440
- Sponsor's protocol ID
- FB03232016
- Status last verified
- Mar 2016
- First submitted
- 27 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Profile and Oxidative Stress Parameters of Patients With Idiopathic Hypogonadotropic Hypogonadism and the Change of These Parameters With Gonadotropin Replacement Therapy
- ClinicalTrials.gov ID
- NCT02728440
- Acronym / sponsor ID
- FB03232016
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Apr 2016 (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.
Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism
Detailed description
30 male patients diagnosed with IHH and a control group of 20 healthy cases with similar age and BMI were included in the study. The levels of advanced oxidation protein products (AOPP), thiol, malondialdehyde (MDA), nitric oxide (NO) and 8-hydroxydeoxyguanosine (8-OHdG) and the levels of triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-K), low density lipoprotein (LDL-K), Apolipoprotein A1 (ApoA1) and Apolipoprotein B100 (ApoB100) were measured before and after gonadotrophin therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypogonadotropic hypogonadism patients | – | Drug: human chorionic gonadotropin, human menopausal gonadotropin30 patients with idiopathic hypogonadotrophic hypogonadism |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with Idiopathic Hypogonadotropic Hypogonadism and healthy control group
Key inclusion criteria (1 listed)
- Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -
Key exclusion criteria (2 listed)
- diabetes mellitus, arterial hypertension other hormone deficiencies
- -
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 |
|---|---|---|
| human chorionic gonadotropin, human menopausal gonadotropinAlso: Pregnyl ® Organon hCG 1500 IU, Merional ® ARIS 75 IUdrug for the treatment of male hypogonadism | Drug | Hypogonadotropic hypogonadism patients |
Primary outcome
oxidative stress after hCG and HMG treatment
Time frame: 2010-2012
HDL levels after hCG treatment
Time frame: 2010-2012
total cholesterole levels after hCG treatment
Time frame: 2010-2012
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 13 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Hypogonadotropic Hypogonadism, run by Gulhane School of Medicine.
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 1 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 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
oxidative stress after hCG and HMG treatment (time frame: 2010-2012). 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 13 Apr 2016.