Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males

NCT ID: NCT03541395

Last Updated: 2018-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Hypogonadism, Male

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

GnRH antagonist

Intervention Type DRUG

Interventions

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GnRH antagonist

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

healthy males

Exclusion Criteria

use of anabolic steroids, use of narcotics,
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Johan Malm

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan Malm, MD

Role: STUDY_CHAIR

Lund University

Roger Appelqvist, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Gyorgy Marko-Varga, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Aleksander Giwercman, MD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Barbara Sahlin, MSc

Role: PRINCIPAL_INVESTIGATOR

Lund University

Other Identifiers

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TP 001

Identifier Type: -

Identifier Source: org_study_id

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