Off-label use of clomiphene citrate to treat anabolic androgenic steroid induced hypogonadism upon cessation among men (CloTASH) – A pilot study protocol
Ingrid Amalia Havnes,
Hans Christian Bordado Henriksen,
Per Wiik Johansen,
Astrid Bjørnebekk,
Sudan Prasad Neupane,
Jonny Hisdal,
Ingebjørg Seljeflot,
Christine Wisløff,
Marie Lindvik Jørstad,
Jim McVeigh,
Anders Palmstrøm Jørgensen
Affiliations
Ingrid Amalia Havnes
Division of Mental Health and Addiction, Oslo University Hospital, PO box 4959 Nydalen, Oslo 0424, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, PO box 1171 Blindern, Oslo 0318, Norway; Corresponding author at: Division of Mental Health and Addiction, Oslo University Hospital, PO box 4959 Nydalen, Oslo 0424, Norway.
Hans Christian Bordado Henriksen
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, PO box 1171 Blindern, Oslo 0318, Norway; Anabolic Androgenic Steroid Research Group, Section for Clinical Addiction Research, Division of Mental Health and Addiction, Oslo University Hospital, PO box 4959 Nydalen, Oslo 0424, Norway
Per Wiik Johansen
National Advisory Unit on Substance Use Disorder Treatment, Division of Mental Health and Addiction, Oslo University Hospital, PO box 4959 Nydalen, Oslo 0424, Norway
Astrid Bjørnebekk
Anabolic Androgenic Steroid Research Group, Section for Clinical Addiction Research, Division of Mental Health and Addiction, Oslo University Hospital, PO box 4959 Nydalen, Oslo 0424, Norway
Sudan Prasad Neupane
National Centre for Suicide Research and Prevention, Institute of Clinical Medicine, University of Oslo, Sognsvannsveien 21, Building 12, Oslo 0372, Norway; Oral Health Centre of Expertise in Rogaland, Torgveien 21 B, Stavanger 4016, Norway
Jonny Hisdal
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, PO box 1171 Blindern, Oslo 0318, Norway; Department of Vascular Surgery, Oslo University Hospital - Aker, Postboks 4959 Nydalen, Oslo 0424, Norway
Ingebjørg Seljeflot
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, PO box 1171 Blindern, Oslo 0318, Norway; Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital - Ullevål, PO box 4954 Nydalen, Oslo 0424, Norway
Christine Wisløff
National Advisory Unit on Substance Use Disorder Treatment, Division of Mental Health and Addiction, Oslo University Hospital, PO box 4959 Nydalen, Oslo 0424, Norway
Marie Lindvik Jørstad
National Advisory Unit on Substance Use Disorder Treatment, Division of Mental Health and Addiction, Oslo University Hospital, PO box 4959 Nydalen, Oslo 0424, Norway
Jim McVeigh
Substance Use and Associated Behaviours Group, Manchester Metropolitan University, Geoffrey Manton Building, 4 Rosamond Street West, Manchester M15 6LL, United Kingdom
Anders Palmstrøm Jørgensen
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, PO box 1171 Blindern, Oslo 0318, Norway; Section of Specialized Endocrinology, Department of Endocrinology, Oslo University Hospital - Rikshospitalet, PO box 4950 Nydalen, Oslo 0424, Norway
Background: Non-prescribed anabolic androgenic steroid (AAS) use is associated with AAS-induced hypogonadism (ASIH), and metabolic, cardiovascular, and mental health risks. Symptoms of ASIH (fatigue, depression, anxiety, sexual dysfunction) are hard to endure following cessation, but there is no consensus on whether endocrine treatment should be used to treat ASIH. This proof-of-concept study aims to explore safety of off-label clomiphene citrate therapy, whether the treatment will reduce the symptoms of androgen deficiency, and to study changes in health risks after cessation. Methods: In this open-labeled non-randomized off-label hormone intervention pilot study, we shall include males with AAS dependence intending to cease use. The 16-week intervention included clomiphene citrate, transdermal testosterone gel for the first four weeks and optional human chorionic gonadotropin (hCG) from week 4 if low treatment response. Measures of physical and mental health will be examined from ongoing AAS use, during the intervention, and at 6- and 12 months post cessation. Change in self-reported symptoms of hypogonadism and other withdrawal symptoms will be compared with data from a group of men who ended AAS use temporarily without the medical intervention. The study may provide valuable clinical insights and may be used to inform the design of future intervention studies.
