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

Phase 1

• Conditions: Crohn's Disease; Hypogonadal; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12620000338965
• Lead Sponsor: Fiona Stanley Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-10
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 46

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified