Hypogonadotropic HypogonadismNCT05184374
Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH
A study testing Gonadorelin in people with Hypogonadotropic Hypogonadism, run by Huashan Hospital at 1 site in China.
Trial summary
The Hypogonadotropic Hypogonadism(HH) could be caused by sellar lesions, sellar surgery or sellar radiotherapy. The incidence of HH after sellar surgery was higher in men than in women, and the therapy of HH was insufficient. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Hypogonadotropic Hypogonadism
- What is being tested?
- Gonadorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- patients with HH after surgery of the saddle area
- sufficient therapy of the hypothalamic-pituitary-adrenal(HPA) and hypothalamic-pituitary-thyroid(HPT) axis
Who cannot join
- contradictions to gonadorelin
- androgen-dependent prostate cancer
- on the therapy of human chorionic gonadotropin(HCG) or testosterone
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Cuiyun Wu, +86(21)52888045, mhe2004@263.net
About this study
Official title: Efficacy of Prolonged Gonadorelin Stimulation Test in Male Adolescents With Postoperative Hypogonadotropic Hypogonadism
The Hypogonadotropic Hypogonadism(HH) could be caused by sellar lesions, sellar surgery or sellar radiotherapy. The incidence of HH after sellar surgery was higher in men than in women, and the therapy of HH was insufficient. Gonadotropin-releasing hormone(GnRH) stimulation test is used to evaluate the function of pituitary-gonadal axis. GnRH can be used to diagnose and treat fertility disorders and other endocrine disorders caused by HH. After a single injection of GnRH, the patients with poor response of luteinizing hormone and follicle stimulating hormone need to take extended provocation test, which is conducive to the formulation of the following treatment. GnRH pump can pulse subcutaneous injection of gonadorelin, which can be used as the extended provocation test.
- Conditions
- Hypogonadotropic Hypogonadism
- Being tested
- Gonadorelin
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GonadorelinDrug
GnRH pump pulse subcutaneous injection of gonadorelin in a month
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous injection of gonadorelin is facilitated by GnRH pump | Experimental | After non-dose GnRH stimulation test on day 1, GnRH pump pulse subcutaneous injection of gonadorelin on the next day until one month. Receives: Drug: Gonadorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of luteinizing hormone, follicle stimulating hormone and testosterone
after the GnRH pump of gonadorelin, the level of luteinizing hormone, follicle stimulating hormone and testosterone will be measured at 24h, 1, 2, 3 and 4 week
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184374
- Sponsor's protocol ID
- KY2021-674
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prolonged Gonadorelin Stimulation Test in Male Adolescents With Postoperative Hypogonadotropic Hypogonadism
- ClinicalTrials.gov ID
- NCT05184374
- Acronym / sponsor ID
- KY2021-674
- Conditions
- Hypogonadotropic Hypogonadism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Jan 2022 (actual)
- 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 Hypogonadotropic Hypogonadism(HH) could be caused by sellar lesions, sellar surgery or sellar radiotherapy. The incidence of HH after sellar surgery was higher in men than in women, and the therapy of HH was insufficient. Gonadotropin-releasing hormone(GnRH) stimulation test is used to evaluate the function of pituitary-gonadal axis. GnRH can be used to diagnose and treat fertility disorders and other endocrine disorders caused by HH. After a single injection of GnRH, the patients with poor response of luteinizing hormone and follicle stimulating hormone need to take extended provocation test, which is conducive to the formulation of the following treatment. GnRH pump can pulse subcutaneous injection of gonadorelin, which can be used as the extended provocation test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subcutaneous injection of gonadorelin is facilitated by GnRH pump | Experimental | Drug: GonadorelinAfter non-dose GnRH stimulation test on day 1, GnRH pump pulse subcutaneous injection of gonadorelin on the next day until one month. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with HH after surgery of the saddle area
- sufficient therapy of the hypothalamic-pituitary-adrenal(HPA) and hypothalamic-pituitary-thyroid(HPT) axis
Key exclusion criteria (3 listed)
- contradictions to gonadorelin
- androgen-dependent prostate cancer
- on the therapy of human chorionic gonadotropin(HCG) or testosterone
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 |
|---|---|---|
| GonadorelinGnRH pump pulse subcutaneous injection of gonadorelin in a month | Drug | subcutaneous injection of gonadorelin is facilitated by GnRH pump |
Primary outcome
level of luteinizing hormone, follicle stimulating hormone and testosterone
Time frame: 1 month
after the GnRH pump of gonadorelin, the level of luteinizing hormone, follicle stimulating hormone and testosterone will be measured at 24h, 1, 2, 3 and 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadorelin in people with Hypogonadotropic Hypogonadism, run by Huashan Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cuiyun Wu (+86(21)52888045, mhe2004@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of luteinizing hormone, follicle stimulating hormone and testosterone (time frame: 1 month). 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 11 Jan 2022.