Back to resultsTestosterone-Dependent Effects on Protein Biomarkers From Healthy Males
Primary Purpose
Hypogonadism, Male
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GnRH antagonist
Sponsored by
About this trial
This is an interventional basic science trial for Hypogonadism, Male
Eligibility Criteria
Inclusion Criteria:
healthy males
Exclusion Criteria:
use of anabolic steroids, use of narcotics,
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Testosterone
Arm Description
A Gonadotropin releasing hormone agonist (GnRH-agonist) is administered to lower the testosterone to castration levels. After four weeks testosterone undecanoate is administered to increase the testosterone to normal levels.
Outcomes
Primary Outcome Measures
Protein biomarkers
Finding new protein biomarkers related to testosterone response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03541395
Brief Title
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males
Official Title
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males Before and After Pharmacological Castration
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Male
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testosterone
Arm Type
Other
Arm Description
A Gonadotropin releasing hormone agonist (GnRH-agonist) is administered to lower the testosterone to castration levels. After four weeks testosterone undecanoate is administered to increase the testosterone to normal levels.
Intervention Type
Drug
Intervention Name(s)
GnRH antagonist
Primary Outcome Measure Information:
Title
Protein biomarkers
Description
Finding new protein biomarkers related to testosterone response
Time Frame
48 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy males
Exclusion Criteria:
use of anabolic steroids, use of narcotics,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Malm, MD
Organizational Affiliation
Lund University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roger Appelqvist, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gyorgy Marko-Varga, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aleksander Giwercman, MD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Sahlin, MSc
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males
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