NCT03541395

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

May 16, 2018

Last Update Submit

May 17, 2018

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (1)

  • Protein biomarkers

    Finding new protein biomarkers related to testosterone response

    48 months

Study Arms (1)

Testosterone

OTHER

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.

Drug: GnRH antagonist

Interventions

GnRH antagonistDRUG
Testosterone

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males

You may not qualify if:

  • use of anabolic steroids, use of narcotics,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Eunuchism

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

HypogonadismGonadal DisordersEndocrine System Diseases

Study Officials

  • Johan Malm, MD

    Lund University

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 30, 2018

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 30, 2018

Record last verified: 2018-05