Hypogonadism, MaleNCT03254641
Calciotropic Effects After HCG Stimulation Test
An observational study of Hypogonadism, Male, run by Martin Blomberg Jensen at 2 sites in Denmark.
Trial summary
We have in a pilot study found that serum calcium levels change in response to hCG stimulation test. We observed that serum calcium level measured at baseline and 72 hours after hCG stimulation were different in men with gonadal insufficiency referred for this stimulation test. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- human chorionic gonadotropin
- How many people
- 242 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Apr 2017to 6 Oct 2021
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: men with suspected gonadal i suffciency ofter after orchiectomy or bilateral irradiation due to testis cancer
Who may be able to join
- men aged 18-60 years referred for hCG stimulation test due to previous treatment for testis cancer
Who cannot join
- high intake calcium
- know disorders in calcium homeostasis
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, 2100
Rigshospitalet
Copenhagen, 2100
About this study
We have in a pilot study found that serum calcium levels change in response to hCG stimulation test. We observed that serum calcium level measured at baseline and 72 hours after hCG stimulation were different in men with gonadal insufficiency referred for this stimulation test. Now we want to investigate a large cohort of men referred for hCG stimulation test due to suspected impaired gonadal function.
Read the detailed description
Introduction:
hCG signals through the LHCGR receptor and is know to stimulate testosterone production. hCG stimulation tests are therefore used to evaulate the capacity of the testis to respond to LH/hCG and thereby determine the degree og gonadal insufficiency and need for testosterone supplementation. Some groups have found LHCRG in extragondal tissues indicating a direct effect of hCG/LH outside the gonads. We noticed that some men with gonadal insuffciency had a low calcium level after hCG stimulation test. Now we would like to investigate whether this putative effect on calcium homeostasis of hCG is due to a direct effect or an indirect effect through testosterone or other sex steroids that also change in response to hCG stimulation. Moreover, we would like to clarify whether the chnage in calcium is compensated by classical regulators such as PTH, 1,25OH2D3, calcitonin, phosphate, CTX, alkaline phosphatase or other factors.
Aim of study:
The purpose of this study is to describe changes in calcium and calciotropic hormones after hCG stimulation test
DESIGN This is a prospective observational study
Patients and methods 100 men referred for hCG stimulation test due to suspected gonadal insuffciency age 18-60 years at Department of growth and reproduction, Rigshospitalet
Exclusion criteria are
intake of high dose calcium (above 1 mg daily) Known Disorders related to calcium metabolism, hypercalcemia, Granulomatous disease such as Wegener, tuberculosis, etc,
SAMPLE SIZE CALCULATION AND STATISTICS By using a test level of 5% (level of significance), power of 80% and at least 100 men completing the trial will enable us to detect a change in calcium of 10%, and a change in serum PTH of 30%.
SCREENING AND TIME COURSE Men referred for hCG stimulation test at ourDepartment will be screened for eligibility to the study. Those who meet the criteria for participation will be informed, and if they consent allocated to the study.
Each person will have one blood sampling performed prior to the test and 72 and 96 hours after the test.
Blood samples Venus blood is drawn preoperatively before hCG administration, 72 and 96 hours after. Serum will be send for analysis within 45 minutes and the rest frozen within 1 hour and will be stored at minus 20 degrees celsius until analysis.
OUTCOME MEASUREMENTS
Primary endpoints
•Changes in total, albumin corrected and ionized calcium
Main Secondary endpoints
- Changes in PTH
- Changes in 1,25OH2D3
- Changes in Phosphate
- Changes in FGF23
- Changes in Calcitonin
- Changes in LHCGR in serum
- Changes in Cortisol
- Changes in total and free testosterone
- Changes in total and free estradiol
- Changes in kidney function (GFR/creatinin)
- Changes in gonadotropins
- Changes in 25OHD, 24,25OH2D3
- Changes in serum concentrations of putative regulators and downstream signals osteocalcin, osteopontin, RANKL, osteoprotegerin (OPG), alpha Klotho, Sclerostin and IGF-1.
Temporal changes in serum level of binding proteins. differences for vitamin D binding protein, albumin and sex hormone binding globulin.
Predefined subgroups orchiectomized men/ bilaterally irradiated testis High versus low baseline estradiol/testosterone Low/high calcium/PTH baseline
ANALYSIS AND INTERVENTION
Reproductive hormones and growth factors will be analysed at dept. of GR, Rigshospitalet. Other serum analyses will be analysed at Department of clinical biochemistry, and Aarhus Kommune Hospital
ETHICS AND SIDE EFFECTS All the patients will have full-filled their investigation, before they are invited to the study. They will be informed of potential adverse effects, and they can leave the trial at any point without any consequences. This study poses no additional risk to the patients except for the blood samples as everything else is according to standard clinical practice.
PUBLICATION OF RESULTS All results, positive or negative will be submitted to peer reviewed scientific journals. Data will successively be obtained and transferred to a statistical database.
- Conditions
- Hypogonadism, Male
- Being tested
- human chorionic gonadotropin
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human chorionic gonadotropinDrug
Also called hCG
5000 IE times one
| Study group | Role | What they receive |
|---|---|---|
| hypogondal men | men referred for hCG stimulation test Receives: Drug: human chorionic gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in total, albumin corrected or ionized calcium
mmol/l
Measured: 72 and 96 hours after hCG injection
Secondary outcomes (11)
PTH
Measured: 72 and 96 hours after hCG injection
1,25OH2D3
Measured: 72 and 96 hours after hCG injection
Phosphate
Measured: 72 and 96 hours after hCG injection
cortisol
Measured: 72 and 96 hours after hCG injection
total and free testosterone
Measured: 72 and 96 hours after hCG injection
total and free estradiol
Measured: 72 and 96 hours after hCG injection
albumin, Shbg, VDBP
Measured: 72 and 96 hours after hCG injection
25OHD or 24,25OH2D3
Measured: 72 and 96 hours after hCG injection
bone factors such as CTX, osteocalcin, RANKL, FGF23
Measured: 72 and 96 hours after hCG injection
LHCGR
in serum
Measured: 72 and 96 hours after hCG injection
kidney function
eGFR/creatinine
Measured: 72 and 96 hours after hCG injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Apr 2017
- Primary completion30 Sep 2020
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypogonadism, MaleStudies 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Blomberg Jensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martin Blomberg Jensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254641
- Sponsor's protocol ID
- H-17004362
- Status last verified
- Oct 2020
- First submitted
- 15 Aug 2017
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share all available data through danish data archive
Publications
Juel Mortensen L, Kooij I, Lorenzen M, Rye Jorgensen N, Roder A, Jorgensen A, Andersson AM, Juul A, Blomberg Jensen M. Injection of luteinizing hormone or human chorionic gonadotropin increases calcium excretion and serum PTH in males. Cell Calcium. 2024 Sep;122:102908. doi: 10.1016/j.ceca.2024.102908. Epub 2024 May 24.
PubMed 38852333
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calciotropic Effects After HCG Stimulation Test
- ClinicalTrials.gov ID
- NCT03254641
- Acronym / sponsor ID
- H-17004362
- Conditions
- Hypogonadism, Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Martin Blomberg JensenUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 18 Aug 2017 (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.
We have in a pilot study found that serum calcium levels change in response to hCG stimulation test. We observed that serum calcium level measured at baseline and 72 hours after hCG stimulation were different in men with gonadal insufficiency referred for this stimulation test. Now we want to investigate a large cohort of men referred for hCG stimulation test due to suspected impaired gonadal function.
Detailed description
Introduction:
hCG signals through the LHCGR receptor and is know to stimulate testosterone production. hCG stimulation tests are therefore used to evaulate the capacity of the testis to respond to LH/hCG and thereby determine the degree og gonadal insufficiency and need for testosterone supplementation. Some groups have found LHCRG in extragondal tissues indicating a direct effect of hCG/LH outside the gonads. We noticed that some men with gonadal insuffciency had a low calcium level after hCG stimulation test. Now we would like to investigate whether this putative effect on calcium homeostasis of hCG is due to a direct effect or an indirect effect through testosterone or other sex steroids that also change in response to hCG stimulation. Moreover, we would like to clarify whether the chnage in calcium is compensated by classical regulators such as PTH, 1,25OH2D3, calcitonin, phosphate, CTX, alkaline phosphatase or other factors.
Aim of study:
The purpose of this study is to describe changes in calcium and calciotropic hormones after hCG stimulation test
DESIGN This is a prospective observational study
Patients and methods 100 men referred for hCG stimulation test due to suspected gonadal insuffciency age 18-60 years at Department of growth and reproduction, Rigshospitalet
Exclusion criteria are
intake of high dose calcium (above 1 mg daily) Known Disorders related to calcium metabolism, hypercalcemia, Granulomatous disease such as Wegener, tuberculosis, etc,
SAMPLE SIZE CALCULATION AND STATISTICS By using a test level of 5% (level of significance), power of 80% and at least 100 men completing the trial will enable us to detect a change in calcium of 10%, and a change in serum PTH of 30%.
SCREENING AND TIME COURSE Men referred for hCG stimulation test at ourDepartment will be screened for eligibility to the study. Those who meet the criteria for participation will be informed, and if they consent allocated to the study.
Each person will have one blood sampling performed prior to the test and 72 and 96 hours after the test.
Blood samples Venus blood is drawn preoperatively before hCG administration, 72 and 96 hours after. Serum will be send for analysis within 45 minutes and the rest frozen within 1 hour and will be stored at minus 20 degrees celsius until analysis.
OUTCOME MEASUREMENTS
Primary endpoints
•Changes in total, albumin corrected and ionized calcium
Main Secondary endpoints
- Changes in PTH
- Changes in 1,25OH2D3
- Changes in Phosphate
- Changes in FGF23
- Changes in Calcitonin
- Changes in LHCGR in serum
- Changes in Cortisol
- Changes in total and free testosterone
- Changes in total and free estradiol
- Changes in kidney function (GFR/creatinin)
- Changes in gonadotropins
- Changes in 25OHD, 24,25OH2D3
- Changes in serum concentrations of putative regulators and downstream signals osteocalcin, osteopontin, RANKL, osteoprotegerin (OPG), alpha Klotho, Sclerostin and IGF-1.
Temporal changes in serum level of binding proteins. differences for vitamin D binding protein, albumin and sex hormone binding globulin.
Predefined subgroups orchiectomized men/ bilaterally irradiated testis High versus low baseline estradiol/testosterone Low/high calcium/PTH baseline
ANALYSIS AND INTERVENTION
Reproductive hormones and growth factors will be analysed at dept. of GR, Rigshospitalet. Other serum analyses will be analysed at Department of clinical biochemistry, and Aarhus Kommune Hospital
ETHICS AND SIDE EFFECTS All the patients will have full-filled their investigation, before they are invited to the study. They will be informed of potential adverse effects, and they can leave the trial at any point without any consequences. This study poses no additional risk to the patients except for the blood samples as everything else is according to standard clinical practice.
PUBLICATION OF RESULTS All results, positive or negative will be submitted to peer reviewed scientific journals. Data will successively be obtained and transferred to a statistical database.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypogondal men | – | Drug: human chorionic gonadotropinmen referred for hCG stimulation test |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- men with suspected gonadal i suffciency ofter after orchiectomy or bilateral irradiation due to testis cancer
Key inclusion criteria (1 listed)
- men aged 18-60 years referred for hCG stimulation test due to previous treatment for testis cancer
Key exclusion criteria (2 listed)
- high intake calcium
- know disorders in calcium homeostasis
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 gonadotropinAlso: hCG5000 IE times one | Drug | hypogondal men |
Primary outcome
change in total, albumin corrected or ionized calcium
Time frame: 72 and 96 hours after hCG injection
mmol/l
11 secondary outcomes
PTH
Time frame: 72 and 96 hours after hCG injection
1,25OH2D3
Time frame: 72 and 96 hours after hCG injection
Phosphate
Time frame: 72 and 96 hours after hCG injection
cortisol
Time frame: 72 and 96 hours after hCG injection
total and free testosterone
Time frame: 72 and 96 hours after hCG injection
total and free estradiol
Time frame: 72 and 96 hours after hCG injection
albumin, Shbg, VDBP
Time frame: 72 and 96 hours after hCG injection
25OHD or 24,25OH2D3
Time frame: 72 and 96 hours after hCG injection
bone factors such as CTX, osteocalcin, RANKL, FGF23
Time frame: 72 and 96 hours after hCG injection
LHCGR
Time frame: 72 and 96 hours after hCG injection
kidney function
Time frame: 72 and 96 hours after hCG injection
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 15 Nov 2024.
- Derived from this study: PubMed 38852333Juel Mortensen L, Kooij I, Lorenzen M, Rye Jorgensen N, Roder A, Jorgensen A, Andersson AM, Juul A, Blomberg Jensen M. Injection of luteinizing hormone or human chorionic gonadotropin increases calcium excretion and serum PTH in males. Cell Calcium. 2024 Sep;122:102908. doi: 10.1016/j.ceca.2024.102908. Epub 2024 May 24.
- Individual participant dataSharing planned: Yes. share all available data through danish data archive
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism, Male, run by Martin Blomberg Jensen at 2 sites in Denmark.
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 15 Nov 2024. 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 Denmark. 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?
change in total, albumin corrected or ionized calcium (time frame: 72 and 96 hours after hCG injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03254641, which also lists 1 linked publication.
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 15 Nov 2024.