An interventional study of Degarelix 120 MG [Firmagon] and Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector in Prostate Cancer Recurrent, sponsored by Lund University. Completed at 1 site in Sweden. Open to male participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Lund University · Not applicable, Interventional, and Other
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.
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.
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This study's enrollment of 33 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Inclusion Criteria: Healthy, non-smoking, body mass index 20-25, Exclusion Criteria: Medication or drug abuse
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At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany) + recombinant FSH (Gonal-f, Merck Serrono S.A. Aubonne, Schweiz), 300 IU every second day for 5 weeks. After 3 weeks: 1000 mg testosterone once.
Drug: Degarelix 120 MG [Firmagon] · Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector · Drug: Testosterone Undecanoate
At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany). After 3 weeks: 1000 mg testosterone (Nebido, Bayer AB, Solna, Sweden) once.
Drug: Degarelix 120 MG [Firmagon] · Drug: Testosterone Undecanoate
Two doses of degarelix, 240 mg, subcutaneously once, at study start.
Also known as: Firmagon
Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.
Also known as: Gonadotropin
One dose 1000 mg testosterone once, after 3 weeks.
Also known as: Nebido
PSA-concentration
Prostate marker
Time frame: 5 weeks
FSH dependent proteins
Proteins identified by spectrophotometry
Time frame: 5 weeks
Plan to share: No
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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