Idiopathic Hypogonadotropic HypogonadismNCT02042638
The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism
An observational study of Idiopathic Hypogonadotropic Hypogonadism, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism. Read more about this study
- Who is it for?
- Ages 16 to 45 years, men only
- Conditions the study is for
- Idiopathic Hypogonadotropic Hypogonadism
- What is being tested?
- hCG 1500 IU three times a week and Pregnyl (hCG) ampule 1500 IU/three times a week
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Aug 2013
- How long will I take part?
- 6 Months
- 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 16 to 45 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Patients with Idiopathic Hypogonadotropic Hypogonadism
Inclusion Criteria: Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -
Exclusion Criteria: Previous androgen treatment, diabetes mellitus, arterial hypertension other hormone deficiencies
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Ankara, 06018
About this study
Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism.
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Being tested
- hCG 1500 IU three times a week, Pregnyl (hCG) ampule 1500 IU/three times a week
- 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.
hCG 1500 IU three times a weekDrug
Also called Pregnyl (Organon) ampule 1500 IU
Pregnyl (hCG) ampule 1500 IU/three times a weekDrug
| Study group | Role | What they receive |
|---|---|---|
| 16 treatment naive Hypogonadotropic hypogonadism patients | Treatment naive 16 patients with idiopathic hypogonadotrophic hypogonadism Receives: Drug: hCG 1500 IU three times a week; Drug: Pregnyl (hCG) ampule 1500 IU/three times a week |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL after hCG treatment
2011-2013
Measured: 2011-2013
LDL levels after hCG treatment
Measured: 2011-2013
total cholesterole levels after hCG treatment
Measured: 2011-2013
Secondary outcomes (2)
Body fat ratio after hCG treatment
Measured: 2011-2013
hsCRP levels after hCG treatment
Measured: 2011-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2011
- Primary completionAug 2013
- Study completionAug 2013
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 only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
- Target duration
- 6 Months
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
- Fahri Bayram, Proffesor, Study director, Erciyes University School of Medicine Depatment of Endocrinology and Metabolism Kayseri TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042638
- Sponsor's protocol ID
- 27122013
- Status last verified
- Dec 2013
- First submitted
- 28 Dec 2013
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism
- ClinicalTrials.gov ID
- NCT02042638
- Acronym / sponsor ID
- 27122013
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Jan 2014 (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 hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 16 treatment naive Hypogonadotropic hypogonadism patients | – | Drug: hCG 1500 IU three times a week, Drug: Pregnyl (hCG) ampule 1500 IU/three times a weekTreatment naive 16 patients with idiopathic hypogonadotrophic hypogonadism |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with Idiopathic Hypogonadotropic Hypogonadism
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 |
|---|---|---|
| hCG 1500 IU three times a weekAlso: Pregnyl (Organon) ampule 1500 IU | Drug | 16 treatment naive Hypogonadotropic hypogonadism patients |
| Pregnyl (hCG) ampule 1500 IU/three times a week | Drug | 16 treatment naive Hypogonadotropic hypogonadism patients |
Primary outcome
HDL after hCG treatment
Time frame: 2011-2013
2011-2013
LDL levels after hCG treatment
Time frame: 2011-2013
total cholesterole levels after hCG treatment
Time frame: 2011-2013
2 secondary outcomes
Body fat ratio after hCG treatment
Time frame: 2011-2013
hsCRP levels after hCG treatment
Time frame: 2011-2013
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 23 Jan 2014.
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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.
Fahri Bayram, Proffesor study director
Erciyes University School of Medicine Depatment of Endocrinology and Metabolism Kayseri TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Hypogonadotropic 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?
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 23 Jan 2014. 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.
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?
HDL after hCG treatment (time frame: 2011-2013). 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 23 Jan 2014.