Testosterone to treat men with mild to moderate Crohn's disease
The effect of Testosterone treatment on disease activity and symptoms in men with mild to moderate Crohn’s disease
Fiona Stanley Hospital
46 participants
Apr 1, 2020
Interventional
Conditions
Summary
Patients with Crohn’s disease (CD) have bowels that are inflamed, which can make the bowel block off or burst. Many patients end up having surgery. Medications can control CD, but in many patients, it doesn’t work, is expensive, and some get side effects. Studies in animals and humans have shown that if testosterone, the main male sex hormone, is low in the patient’s blood, then signs of inflammation are seen more often. You can increase the testosterone level in the blood by giving testosterone to the patient (e.g. with a skin patch), and higher levels might make the Crohn’s disease better, as shown in some older studies. These older studies had few patients and weren’t very good quality. We want to see if giving testosterone with a skin patch for 12 weeks to men with CD that have low to low-normal levels can make their CD better.
Eligibility
Inclusion Criteria5
- (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.
Exclusion Criteria10
- (i) Any patient on biologic (as this defines them as having moderate to severe disease).
- (ii) Any patient at imminent risk of a bowel resection.
- (iii) Patients having active obstructive symptoms at randomisation.
- (iv) A short gut (<1.5m of small bowel remaining) or an ileostomy.
- (v) Abnormal liver function test with ALT >3x the upper limit of normal
- (vi) An abnormal prostate exam or high PSA levels as defined by laboratory cut-off specific for age.
- (vii) A history of prostate or breast cancer.
- (viii) Any hypothalamic, pituitary or testicular disease resulting in androgen deficiency necessitating testosterone replacement therapy
- (ix) Use of testosterone or other androgens within the past 12 months
- (x) Use of high dose opioids, or other medications interfering with testosterone production or action (e.g. long-acting GnRH agonists or androgen receptor antagonists), in the past six months
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Interventions
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.
Locations(2)
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ACTRN12620000338965