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OpenTrials
Completed

NCT Number: NCT04134130

The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

In order to elucidate if FSH can have testosterone like effects, samples from young, non-smoking healthy volunteers, with normal body mass index, and with pharmacologically induced gonadotropin deficiency will be studied regarding their capacity to induce prostate specific antigen (PSA), which normally is regulated by testosterone.

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Key information

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medicine Center

Malmö, 21428, Sweden

About this study

Normally, prostate specific antigen (PSA), which is a marker for prostate disease and progression, is exclusively produced in response to testosterone. In order to elucidate if follicle stimulating hormone (FSH) can have testosterone like effects, samples from n=30 non-smoking healthy volunteers, 20-30 years of age and with normal body mass index (20-25) with pharmacologically induced gonadotropin deficiency will be studied. The men are currently recruited and during 5 weeks undergoing:

  • Pharmacologically induced gonadotropin deficiency w 1-3;
  • FSH-treatment of 50% (group A), w 1-5;
  • Testosterone (T) treatment of all (group A and B) w 4-5;
  • End and follow up after 5 weeks.

A subcutaneous injection with the GnRH antagonist degarelix (240 mg¸ Ferring GmbH Wittland, Kiel, Germany) results in drop of both FSH and LH-induced testosterone. Half of the men will get recombinant FSH (300 IU; Gonal-f, Merck Serrono S.A. Aubonne, Schweiz) back, whereas 50% will not. Three weeks thereafter, the full spectrum of FSH dependent changes occur and are reflected in blood. From this occasion testosterone (Nebido, Ferring GmbH Wittland, Kiel, Germany) will be given to all participants to diminish the side-effects of the castration. Blood samples are collected at start, after 3 wks and after 5 wks. At that point also a follow up is undertaken. This experimental design will provide samples from each individual during normal conditions, during castration, and after a standardised dose of FSH.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy, non-smoking, body mass index 20-25, Exclusion Criteria: Medication or drug abuse

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Treatment and study plan

Degarelix 120 MG [Firmagon]

Drug

Two doses of degarelix, 240 mg, subcutaneously once, at study start.

Other names: Firmagon

Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector

Drug

Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.

Other names: Gonadotropin

Testosterone Undecanoate

Drug

One dose 1000 mg testosterone once, after 3 weeks.

Other names: Nebido

Primary outcomes

  1. PSA-concentration

    Time frame: 5 weeks

    Prostate marker

Secondary outcomes

  1. FSH dependent proteins

    Time frame: 5 weeks

    Proteins identified by spectrophotometry

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • ALF Swedish Government Grant
  • Swedish Cancer Foundation

Registry information

Official study title

Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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