Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males

Not Applicable

Completed

• Conditions: Hypogonadism, Male
• Interventions: Drug: GnRH antagonist

• Registration Number: NCT03541395
• Lead Sponsor: Lund University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-05
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-17
• Last Update Submitted: 2018-05-17
• Study First Posted: 2018-05-30
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

healthy males

Exclusion Criteria

use of anabolic steroids, use of narcotics,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Testosterone	GnRH antagonist	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.

Primary Outcome Measures

Name	Time	Method
Protein biomarkers	48 months	Finding new protein biomarkers related to testosterone response