Extragonadal Effects of hCG on Calcium Homeostasis

NCT03418896 | Completed Phase 1 DMC

• 1 other identifier: 2016-003546-84
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

A pilot study showed that serum calcium levels and calcium homeostasis change in response to hCG stimulation test. Serum calcium level differed when comparing pretreatment values at baseline with serum levels 72 hours after hCG stimulation in men with gonadal insufficiency referred for this stimulation test. Now we want to investigate whether this change in calcium is due to renal loss or other mechanisms and how the classical regulators of calcium homeostasis respond to hCG in men with impaired gonadal function compared with men having normal gonadal function. Moreover, the observed change in serum calcium implies that hCG also changes Phosphate, PTH and calcitonin and this will be clarified with this study

Conditions

Hypogonadism; Calcium Disorder; Renal Disease

Outcome Measures

Primary Outcomes (1)

• Serum calcium

  changes albumin corrected calcium, ionized calcium, total calcium

  2,8,24, 72,120 hours

Secondary Outcomes (2)

• urinary calcium and phosphate excretion

  2,8,24, 72,120 hours

• serum Phosphate

  2,8,24, 72,120 hours

Other Outcomes (20)

• vitamin D metabolites

  2,8,24, 72,120 hours

• calcitonin

  2,8,24, 72,120 hours

• Cortisol

  2,8,24, 72,120 hours

Study Arms (1)

human chorion gonadotropin

EXPERIMENTAL

Pregnyl, hCG, 5000 IU times one im.

Drug: human chorionic gonadotropin

Interventions

human chorionic gonadotropin DRUG

a single injection of a standard dose

human chorion gonadotropin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a man with normal reproductive function
• or a man with known impaired gonadal function
• more than 18 years of age and less than 80 years of age

You may not qualify if:

• presence of current serious diseases
• or presence of disease requiring constant and lifelong treatment with chemotherapy or other toxic drugs
• Men treated with testosterone who do not stop their treatment while being part of the study,

Sponsors & Collaborators

• Martin Blomberg Jensen: lead

Study Sites (2)

Department of Growth and Reproduction, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Juel Mortensen L, Lorenzen M, Jorgensen A, Albrethsen J, Jorgensen N, Moller S, Andersson AM, Juul A, Blomberg Jensen M. Possible Relevance of Soluble Luteinizing Hormone Receptor during Development and Adulthood in Boys and Men. Cancers (Basel). 2021 Mar 16;13(6):1329. doi: 10.3390/cancers13061329.

  PMID: 33809538 DERIVED

MeSH Terms

Conditions

Hypogonadism; Kidney Diseases

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Martin blomberg Jensen

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Group leader, MD, DMSc

Model Details: simple one arm intervention study

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: February 1, 2018
• Study Start: January 6, 2018
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

DK (2)