Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment

Who is this study for? Adult patients with congenital adrenal hyperplasia
What treatments are being studied? Conventional Glucocorticoids+Dual release hydrocortisone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is a controlled, open study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on clinical, anthropometric parameters, metabolic syndrome, hormonal profile, bone status, quality of life, reproductive, sexual and psychological functions and treatment compliance in patients affected by congenital adrenal hyperplasia due to 21 OH deficiency.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• males and females aged \>18 years;

• established diagnosis of adrenal insufficiency in congenital adrenal hyperplasia due to 21-hydroxylase deficiency;

• stably treated with conventional glucocorticoids, available to change their regimen according to random allocation

• written informed consent/assent to participate in the study in compliance with local regulations.

Locations
Other Locations
Italy
Federico II University
RECRUITING
Naples
Contact Information
Primary
Rosario Pivonello, M.D., PhD, Professor
rosario.pivonello@unina.it
+390817464983
Time Frame
Start Date: 2016-08-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 150
Treatments
Experimental: Dual-release hydrocortisone
Active_comparator: Conventional glucocorticoids
Sponsors
Leads: Federico II University

This content was sourced from clinicaltrials.gov