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Trial record 12 of 109 for:    CALCIUM CATION

Calciotropic Effects After hCG Stimulation Test

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ClinicalTrials.gov Identifier: NCT03254641
Recruitment Status : Active, not recruiting
First Posted : August 18, 2017
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Blomberg Jensen, Rigshospitalet, Denmark

Brief 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. Now we want to investigate a large cohort of men referred for hCG stimulation test due to suspected impaired gonadal function.

Condition or disease Intervention/treatment
Hypogonadism, Male Drug: human chorionic gonadotropin

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Calciotropic Effects After hCG Stimulation Test
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
hypogondal men
men referred for hCG stimulation test
Drug: human chorionic gonadotropin
5000 IE times one
Other Name: hCG




Primary Outcome Measures :
  1. change in total, albumin corrected or ionized calcium [ Time Frame: 72 and 96 hours after hCG injection ]
    mmol/l


Secondary Outcome Measures :
  1. PTH [ Time Frame: 72 and 96 hours after hCG injection ]
  2. 1,25OH2D3 [ Time Frame: 72 and 96 hours after hCG injection ]
  3. Phosphate [ Time Frame: 72 and 96 hours after hCG injection ]
  4. cortisol [ Time Frame: 72 and 96 hours after hCG injection ]
  5. total and free testosterone [ Time Frame: 72 and 96 hours after hCG injection ]
  6. total and free estradiol [ Time Frame: 72 and 96 hours after hCG injection ]
  7. albumin, Shbg, VDBP [ Time Frame: 72 and 96 hours after hCG injection ]
  8. 25OHD or 24,25OH2D3 [ Time Frame: 72 and 96 hours after hCG injection ]
  9. bone factors such as CTX, osteocalcin, RANKL, FGF23 [ Time Frame: 72 and 96 hours after hCG injection ]
  10. LHCGR [ Time Frame: 72 and 96 hours after hCG injection ]
    in serum

  11. kidney function [ Time Frame: 72 and 96 hours after hCG injection ]
    eGFR/creatinine


Biospecimen Retention:   Samples Without DNA
serum


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   referred for hCG stimulation test
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
men with suspected gonadal i suffciency ofter after orchiectomy or bilateral irradiation due to testis cancer
Criteria

Inclusion Criteria:

- men aged 18-60 years referred for hCG stimulation test due to previous treatment for testis cancer

Exclusion Criteria:

  • high intake calcium
  • know disorders in calcium homeostasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254641


Locations
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Denmark
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark, 2100
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Martin Blomberg Jensen

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Responsible Party: Martin Blomberg Jensen, MD, group leader, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03254641     History of Changes
Other Study ID Numbers: H-17004362
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: share all available data through danish data archive
Supporting Materials: Study Protocol
Time Frame: 2 years after study completion

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs