CompletedPhase 3

Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome

Belgium, Germany50 participantsStarted 2015-04

Plain-language summary

The purpose of this prospective, international phase III/IV study is to assess the efficacy and safety of metyrapone in patients with endogenous Cushing's syndrome during up to 36 weeks of treatment. The ability of metyrapone (250 mg capsules) to normalize urinary free cortisol (UFC) levels will be assessed during up to 36 weeks (9 months) of treatment.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Pseudo Cushing's syndrome
✕. Cyclic Cushing's syndrome defined by at least one normal UFC value among at least three 24-hour urinary sampling measurements over the previous 2 months
✕. Advanced adrenocortical carcinoma or ectopic ACTH secretion (EAS) secondary to a small cell lung carcinoma
✕. Life expectancy less than 3 months
✕. Pituitary or adrenal surgery or pituitary irradiation or surgery of the ACTH-secreting ectopic tumor or bilateral adrenalectomy planned before the week 12 visit
✕. Pituitary irradiation within the previous 5 years (for Cushing's disease patients)
✕. Enlarged pituitary adenoma (greater than 1 cm in vertical diameter and leaving less than 2 mm from the chiasma) or compression of the optic chiasma on the pituitary MRI for patients with Cushing's disease
✕. Severe uncontrolled hypertension (\>180/110 mmHg) despite anti-hypertensive therapy (for otherwise eligible patients, blood pressure medication may be adjusted to meet this criterion)

What they're measuring

Normalization of cortisol levels (urinary free cortisol)

Timeframe: 3 months

Trial details

NCT IDNCT02297945

SponsorHRA Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11

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