Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males

Hypogonadism, Male Clinical Trial

Official title:

Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males Before and After Pharmacological Castration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541395
• Other study ID #: TP 001
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: May 2018
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

healthy males

Exclusion Criteria:

use of anabolic steroids, use of narcotics,

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male

Intervention

Drug:
• GnRH antagonist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein biomarkers	Finding new protein biomarkers related to testosterone response	48 months