Reproductive Medicine Center
Malmö, 21428, Sweden
NCT Number: NCT04134130
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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Notify Me20 year–30 year
Male
Interventional
Not applicable
Malmö, 21428, Sweden
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:
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.
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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Two doses of degarelix, 240 mg, subcutaneously once, at study start.
Other names: Firmagon
Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.
Other names: Gonadotropin
One dose 1000 mg testosterone once, after 3 weeks.
Other names: Nebido
Time frame: 5 weeks
Prostate marker
Time frame: 5 weeks
Proteins identified by spectrophotometry
Lund University
Other
Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men
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