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Optimizing timing of glucocorticoid treatment in children with congenital adrenal hyperplasia

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.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment (CAHTALYST)

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…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia

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…

A phase 1/2 trial of EO2401, a novel microbial-derived peptide therapeutic vaccine, in combination with PD-1 check point blockade, for treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma

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.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia

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 *…

Novel treatment of adrenal crisis: an early clinical trial with nebulized prednisolone

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…

[18F]mFBG PET-CT imaging of pheochromocytoma

This study has been transitioned to CTIS with ID 2024-513622-35-00 check the CTIS register for the current data. The primary objective of this study is to assess the number of detected pheochromocytoma lesions, proved by histology, with [18F]mFBG…

Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant

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…

The perception of adult females diagnosed with CAH on childhood feminising surgery.

The perception of adult females diagnosed with CAH, who underwent genital surgery in childhood, on early feminizing surgery.

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The stress hormone COrtisol and the development of MEtabolic Syndrome and Cardiovascular DIseases
Unravelling the cause(s) of hypercortisolism in obesity:
Investigating the influence of the liver, gut and immune system

Primary Objective: - To investigate the differences between hypercortisolistic patients with obesity and normocortisolistic patients with obesity, with respect to hepatic steatosis, immunological factors, and the gut microbioma in order to obtain…

The effect of discontinuing estrogen containing oral contraceptives on corticosteroid-binding globulin and total cortisol concentrations

In this study we look at how long it takes for the levels of certain hormones and hormone-binding proteins to normalizediscontinuation of COC use, in particular corticosteroid-binding globulin.

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

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…

An Open-Label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the
Treatment of Endogenous Cushing*s Syndrome

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).

CXCR4-directed [68Ga]Ga-PentixaFor PET/CT vs AVS performance in a diagnoStic randomized Trial Ultimately comparing hypertenSion outcome in primary aldosteronism

This study has been transitioned to CTIS with ID 2024-512628-12-00 check the CTIS register for the current data. Primary objectives-To assess the concordance between [68Ga]Ga-PentixaFor PET/CT and AVS for identification and/or lateralization of APAs…

Bioequivalence study of prednisolone and dexamethasone; corticosteriods revised

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.

To test the use of a Microdialysate Automated Collection Device for cortisol sampling and to assure reproducibility in the LUMC of data reported by others

- To assure reproducibility of results reported by other groups to see whether the current SOP should be adjusted for local use in order to let the device be of value to future research projects of our department. - To confirm the ability to measure…

An Open Label Study to Assess the Safety and Efficacy of COR*003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

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.

Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing*s Syndrome

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…

A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

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…