Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males
May 17, 2018 updated by: Johan Malm, Lund University
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males Before and After Pharmacological Castration
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
healthy males
Exclusion Criteria:
use of anabolic steroids, use of narcotics,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Testosterone
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Protein biomarkers
Time Frame: 48 months
|
Finding new protein biomarkers related to testosterone response
|
48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Johan Malm, MD, Lund University
- Principal Investigator: Roger Appelqvist, PhD, Lund University
- Principal Investigator: Gyorgy Marko-Varga, PhD, Lund University
- Principal Investigator: Aleksander Giwercman, MD, Lund University
- Principal Investigator: Barbara Sahlin, MSc, Lund University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2015
Primary Completion (ACTUAL)
June 1, 2015
Study Completion (ACTUAL)
June 1, 2015
Study Registration Dates
First Submitted
May 16, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (ACTUAL)
May 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 30, 2018
Last Update Submitted That Met QC Criteria
May 17, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.