ACTRN12620000338965
Not yet recruiting
Phase 1
The effect of Testosterone treatment on disease activity and symptoms in men with mild to moderate Crohn’s disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fiona Stanley Hospital
- Enrollment
- 46
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
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