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therapy with Plenadren in patients with central hypoadrenalism.

Replacement therapy with modified-release hydrocortisone (Plenadren) in patients with central adrenal insufficiency - PLEN2013

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-004028-12-IT
Enrollment
Unknown
Registered
2014-01-22
Start date
2014-05-13
Completion date
Unknown
Last updated
2014-06-30

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

Conditions

Central hypoadrenalism MedDRA version: 16.1 Level: LLT Classification code 10020936 Term: Hypoadrenalism System Organ Class: 100000004860

Interventions

Trade Name: Plenadren 20 mg Pharmaceutical Form: Modified-release tablet INN or Proposed INN: HYDROCORTISONE Other descriptive name: HYDROCORTISONE Concentration unit: mg milligram(s) Concentration t

Sponsors

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: •Age > 18 years •Diagnosis of central hypoadrenalism •Other pituitary deficiencies in adequate replacement therapy •Therapy with cortisone acetate from at least six months •Symptoms of over- and under-treatment •Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: •Pregnancy •Breast feeding •Estroprogestinic therapy •Steroids assumption

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the medium-term effects of the therapy with modified-release hydrocortisone on glucose, bone metabolism, and quality of life, compared to the classical therapy;Secondary Objective: To compare cortisol absorption pattern through evaluation of salivary cortisol, between patients treated with cortisone acetate and Plenadren.;Primary end point(s): Evaluation of effects of Plenadren on: - glucose metabolism (modifications of fasting glucose and glycated haemoglobin) - bone metabolism (modification of bone mineral density, BMD) - blood pressure (modification of systolic and diastolic blood pressure) - quality of life (modification evaluated by specific questionnaires);Timepoint(s) of evaluation of this end point: 18 months—

Secondary

MeasureTime frame
Secondary end point(s): Cortisol absorption pattern through evaluation of salivary cortisol during therapy with Plenadren.;Timepoint(s) of evaluation of this end point: 3 months—

Countries

Italy

Contacts

Public ContactAnna Spada

U.O. Endocrinologia e Diabetologia Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

anna.spada@unimi.it0039255033356

Outcome results

None listed

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