Testosterone to treat men with mild to moderate Crohn's disease

INTERVENTION: This will be a prospective randomised double blind placebo controlled study. Randomised 1:1, placebo: intervention using random number generator Group 1: to receive 100mg, once daily, transdermal testosterone cream in addition to existing stable medical therapy for a period of 12 weeks, n=23. Group 2: matching 100mg, once daily, placebo in addition to existing stable medical therapy for a period of 12 weeks, n=23. Cream will be applied to the arm with arms being rotated each day to ensure maximum absorbation and less irritation to the skin. All transdermal cream patches will be counted at each visit to ensure compliance with investigational therapy. Stable therapies include: a. Immunosuppressant (Azathioprine, 6‐Mercaptopurine or methotrexate) for 4 weeks prior to enrollment. b. 5 ASA medication (mesalazine, olsalazine, sulfasalazine) for 4 weeks prior to enrollment. c. Corticosteroids for 14 days before enrollment with a dose no higher than the equivalent of 5 mg of prednisolone or 3mg of budesonide. Patients on biologic medication such as infliximab, vedolizumab, adalimumab or ustekinumab will be excluded. CONDITION: Crohn's Disease;Hypogonadal; ; Crohn's Disease ; Hypogonadal Oral and Gastrointestinal ‐ Crohn's disease PRIMARY OUTCOME: Composite Outcome. The proportion of intervention and placebo treated participants that achieve clinical remission (CDAI less than 150) AND either a faecal calprotectin level of equal to or less than 100umol/ml and/or simple endoscopic score (SES) of less than 4.; ; CDAI scores are assessed from patient symptoms and blood tests, Faecal calprotectin is assessed with a faecal sample and simple endoscopic score is assessed using a standard of care colonoscopy. [Week 12 post intervention commencement] SECONDARY OUTCOME: The change in C‐reactive protein from baseline (week 0) to end of study (week 12) between the two treatment groups. ; ; Blood samples will be taken and serum assay's anaylsed. [Week 12 post intervention commencement] The change in faecal calprotectin level from baseline (week 0) to end of study (week 12) between the two treatment groups. ; ; Faecal Samples will collected to measure this. [Week 12 post intervention commencement] The change in IBDQ (Inflammatory bowel disease quality of life) score from baseline (week 0) to end of study (week 12) between the two treatment groups.[Week 12 post intervention commencement] The change in intestinal ultrasound score (Novak score) from baseline (week 0) to end of study (week 12) between the two treatment groups.[Week 12 post intervention commencement] The change in testosterone levels from baseline (week 0) to end of study (week 12) between the two treatment groups. ; ; Blood samples will be taken and serum assay's anaylsed. ; [Week 12 post intervention commencement] INCLUSION CRITERIA: (i) Adult men (aged 18 years to 70 years) with mild to moderate Crohn’s disease activity as defined by the Crohn’s disease activity index (CDAI) score of 150‐300 AND objective evidence of disease activity with either a raised faecal calprotectin equal to or greater than 250 and/or evidence of active inflammation on colonoscopy, with low‐normal levels of testosterone (14 nmol/L or less) at screening will be eligible to participate. (ii) Enter on a stable dose of the following medications at the time of randomisation. a. Immunosuppressant (Azathioprine, 6MP or methotrexate) for 4 weeks prior to randomisation. b. 5 ASA medication (mesalazine, olsalazine, sulfasalazine) for 4 weeks prior to randomisation. c. Corticosteroids for 14 days before randomisation with a dose no higher than the equivalent of 5 mg of prednisolone or 3mg of budesonide.