NCT03254641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2021

Completed
Last Updated

November 15, 2024

Status Verified

October 1, 2020

Enrollment Period

3.5 years

First QC Date

August 15, 2017

Last Update Submit

November 13, 2024

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (1)

  • change in total, albumin corrected or ionized calcium

    mmol/l

    72 and 96 hours after hCG injection

Secondary Outcomes (11)

  • PTH

    72 and 96 hours after hCG injection

  • 1,25OH2D3

    72 and 96 hours after hCG injection

  • Phosphate

    72 and 96 hours after hCG injection

  • cortisol

    72 and 96 hours after hCG injection

  • total and free testosterone

    72 and 96 hours after hCG injection

  • +6 more secondary outcomes

Study Arms (1)

hypogondal men

men referred for hCG stimulation test

Drug: human chorionic gonadotropin

Interventions

human chorionic gonadotropinDRUG

5000 IE times one

Also known as: hCG
hypogondal men

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsreferred for hCG stimulation test
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

men with suspected gonadal i suffciency ofter after orchiectomy or bilateral irradiation due to testis cancer

You may qualify if:

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

You may not qualify if:

  • high intake calcium
  • know disorders in calcium homeostasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Growth and Reproduction, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Eunuchism

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

HypogonadismGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, group leader

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 18, 2017

Study Start

April 1, 2017

Primary Completion

September 30, 2020

Study Completion

October 6, 2021

Last Updated

November 15, 2024

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

share all available data through danish data archive

Shared Documents
STUDY PROTOCOL
Time Frame
2 years after study completion

Locations

DK(2)