A trial with Metyrapone in Cushing's syndrome

A prospective open-label Phase 2 study of METYRAPONE as a preoperative treatment in patients with ACTH-independent Cushing’s syndrome due to adrenal adenoma. - METYX01

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002063-26-IT

Enrollment

Registered

2013-07-23

Start date

2013-09-08

Completion date

Unknown

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing's syndrome

Interventions

Trade Name: Matyrapone Product Name: Metyrapone Product Code: Metyrapone Pharmaceutical Form: Capsule, soft

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Both sexes and age= 18 years - Confirmed diagnosis of ACTH-independent Cushing’s syndrome validated by all the following criteria: • two 24 h urinary collections for UFC at least 1.5 times the upper normal value, within 2 weeks prior to enrollment. • levels of serum ACTH lower than the normal range • CT-confirmed diagnosis of adrenal adenoma (size 2-4 cm, regular shape and margins, homogeneous density =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Patients who meet any of the following exclusion criteria are not eligible for enrollment. - Prior metyrapone therapy - Mitotane therapy within 6 months prior entering the study (mitotane levels should be undetectable prior to enrollment) - Cushing’s syndrome with ACTH levels that are not clearly suppressed - Hypercortisolism due to an adrenal tumor of uncertain dignity (suspicious for malignancy)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the efficacy of METYRAPONE in attaining normalization of 24-h urinary free cortisol (UFC) excretion or a =50% decrease from baseline using the mean of 2 UFC measurements within 3 months of treatment. ;Secondary Objective: • time to response • dose-response relationship • effect of METYRAPONE on levels of serum cortisol, UFC, salivary cortisol, ACTH, 11-deoxicortisol, deoxycorticosterone, total testosterone, androstenedione, DHEA-S in terms of percent variation relative to baseline. • improvement of the clinical signs associated to hypercortisolism (blood pressure, body mass index, waist) ;Primary end point(s): Primary All patients will be included in the efficacy analysis. The primary efficacy variable is UFC. ;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the efficacy of METYRAPONE in attaining normalization of 24-h urinary free cortisol (UFC) excretion or a =50% decrease from baseline using the mean of 2 UFC measurements within 3 months of treatment. ;Secondary Objective: • time to response • dose-response relationship • effect of METYRAPONE on levels of serum cortisol, UFC, salivary cortisol, ACTH, 11-deoxicortisol, deoxycorticosterone, total testosterone, androstenedione, DHEA-S in terms of percent variation relative to baseline. • improvement of the clinical signs associated to hypercortisolism (blood pressure, body mass index, waist) ;Primary end point(s): Primary All patients will be included in the efficacy analysis. The primary efficacy variable is UFC. ;Timepoint(s) of evaluation of this end point: 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy variables include other hormones (including serum and salivary cortisol levels), laboratory tests, and clinical signs and symptoms.;Timepoint(s) of evaluation of this end point: 3 months	—

Countries

Italy

Contacts

Public ContactStudy Coordinator

S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano

oncotrial.sanluigi@gmail.com00390119026513

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026