sperimentation only in patients
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tretinoin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
ISTITUTO AUXOLOGICO ITALIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: adult males or postmenopausal women; patients awaiting surgery, surgical failures or relapses; 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion: women in child-bearing age; children, patients submitted to pituitary radiosurgery/radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoint of the study is to estabilish the efficacy of retinoic acid treatment in patients with Cushing`s disease, a disorder as yet lacking causal medical therapy. Efficacy of retinoic acid will be evaluated in terms of decrease in ACTH and cortisol concentrations and improvement in features of hypercortisolism. Retinoic acid treatment is expected to lower hormone concentrations and ameliorate clinical features compared with the same prior to treatment. An additional primary objective is the evaluation of the safety profile of long-term retinoic acid administration to patients with Cushing`s disease, thus defining its benefit-risk ratio.;Secondary Objective: Secondary endpoint of the study is to establish whether the cortisol-lowering effects of retinoic acid in Cushing`s disease result in a reduction in symptomatic drug requirements, i.e., drugs used to treat complications of chronic hypercortisolism such as antihypertensive medication, oral hypoglycemic agents and/or insulin, antidepressant and antidislipidemic drugs.;Primary end point(s): Primary endpoint of the study is to estabilish the efficacy of retinoic acid treatment in patients with Cushing`s disease, a disorder as yet lacking causal medical therapy. Efficacy of retinoic acid will be evaluated in terms of decrease in ACTH and cortisol concentrations and improvement in features of hypercortisolism, e.g., glucose tolerance, insulin resistance, dyslipidemia, hypertension, weight excess, proximal muscle hypotrophy, osteopenia/osteoporosis, intraocular pressure and psychiatric disturbances. Retinoic acid treatment is expected to lower hormone concentrations and ameliorate clinical features compared with the same prior to treatment. An additional primary objective is the evaluation of the safety profile of long-term retinoic acid administration to patients with Cushing`s disease, thus defining its benefit-risk ratio.Aim of the present study is to establish the efficacy of re | — |
Countries
Italy
Outcome results
None listed