21 results
The aim of this study is to determine whether children between 5-17 years born to women with an autoimmune disorder and prednisone use during pregnancy have chronically elevated cortisol levels compared to children born to women with an autoimmune…
Primary objective:We hypothesize that genetic variability influences mitotane pharmacokinetics. Therefore our aim is to explore the inter-individual differences in genes coding for drug metabolizing enzymes in patients treated with mitotane and to…
The primary aim of this study is to investigate the recovery of the circadian rhythm of the hypothalamic-pituitary-adrenal axis during a glucocorticoid tapering regime. Secondary objectives include the effect of a tapering regime on melatonin rhythm…
Primary objectiveTo compare the efficacy of adjuvant mitotane treatment vs observational follow-up only in prolonging recurrence free survival (RFS) in patients with ACC after complete resection and low-intermediate risk for disease recurrence.…
The main objective of this study is to construct a population-pharmacokinetic model, in order to evaluate the influence of patient characteristics on the pharmacokinetics of mitotane in patients treated with this oral therapy.
The primary objective is to determine which of two commonly used drugs for preoperative management provides the best intraoperative hemodynamic control in patients undergoing resection of a PCC. Secondary Objective(s): o to identify other…
To study the effects of 2 standard treatment timing strategies for glucocorticoid dosage on androgen concentration in CAH children: a. highest dosage in the morning, b. highest dosage in the evening.
The purpose of this study is to see if Crinecerfont is effective in reducing daily glucocorticoid dosage while maintaining adrenal androgen control.The purpose of the study is also to see if Crinecerfont is effective in reducing adrenal steroid…
This study has been transitioned to CTIS with ID 2023-503771-13-00 check the CTIS register for the current data. The purpose of this study is to see if tildacerfont can reduce the amount of GC (e.g., hydrocortisone) you need to take and reduce the…
The objective of this trial is to evaluate safety and tolerability of an experimental drug, EO2401, in combination with another immunological treatment, nivolumab, in patients with advanced or metastatic ACC and progressive MPP.
The primary purpose of this study is to assess the dose response of several doses of tildacerfont in controlling hormone levels and reducing testicular tumors over 12 weeks by comparing the tildacerfont hormonal control response to a placebo, a *…
The aim of this study is to establish pharmacokinetic data on inhaled nebulized prednisolone: Time from start nebulizing to serum peak prednisolone concentration (Tmax) and prednisolone area under. We derive this pharmacokinetic data from two…
Primary • To assess the efficacy of relacorilant for the treatment of endogenous Cushing syndrome based on BP control at Week 12 of the Randomized- Withdrawal (RW) phase compared with placebo• To assess the safety of relacorilant for the treatment…
Primary Objectives: Safety Assessments: Effect of Administration of Relacorilant on: • Incidence of TEAEs (assessed monthly): TEAEs, SAEs, treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment• Clinical laboratory tests…
The objective of this study is to assess long-term safety and efficacy durability of levoketoconazole as chronic treatment for endogenous Cushing*s Syndrome (CS).
This study aims to re-examine the bioequivalence of prednisolone and dexamethasone at two different doses by assessing tissue specific glucocorticoids effects, including the immune system, brain functioning, hormonal axes, and renal parameters.
This study will be a single arm, open-label, dose titration study to assess efficacy, safety, tolerability and PK of COR-003 in subjects with CS with each subject serving as his/her own control.
The primary objective of the study is to assess the safety of CORT125134 in patients with endogenousCushing*s syndrome. The secondary objective of the study is to assess the evidence of reduction incortisol activity following treatment with…
Primary: To determine the effect of withdrawing to placebo versus continuing treatment with levoketoconazole on the cortisol therapeutic response previously established during open-label levoketoconazole therapy.Secondary:1. To compare the effects…