Phase
Condition
Male Hormonal Deficiencies/abnormalities
Congenital Adrenal Hyperplasia
Treatment
Chronocort
Clinical Study ID
Ages > 16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with Congenital Adrenal Hyperplasia (CAH) who have successfullycompleted Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014.
Participants who are capable of giving signed informed consent/assent, whichincludes compliance with the requirements and restrictions listed in the study'sinformed consent form (ICF) and in the protocol.
Exclusion
Exclusion Criteria:
Participants with clinical or biochemical evidence of hepatic or renal disease e.g.,creatinine >2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times theULN).
Participants with a history of malignancy (other than basal cell carcinomasuccessfully treated >26 weeks prior to entry into the study).
Participants with a history of bilateral adrenalectomy.
Participants with any other significant medical or psychiatric conditions that inthe opinion of the Investigator would preclude participation in the study.
Participants with a co-morbid condition requiring daily administration of amedication or consumption of any material that interferes with the metabolism ofglucocorticoids.
Participants on regular daily inhaled, topical, nasal, or oral steroids for anyindication other than CAH.
Participants anticipating regular prophylactic use of additional steroids e.g., forstrenuous exercise.
Participation in another clinical study of an investigational or licensed drug ordevice within 3 months prior to inclusion in this study, except for another clinicalstudy with the current formulation of Chronocort.
Females who are pregnant or lactating.
Participants, who in the opinion of the Investigator, will be unable to comply withthe requirements of the protocol.
Participants who routinely work night shifts and so do not sleep during the usualnight-time hours.
Participants with a body weight of 50 kg or less (Note: this exclusion criterion isonly applicable for French sites).
Study Design
Study Description
Connect with a study center
Diurnal Investigational Site in Caen
Caen, 14033
FranceSite Not Available
Diurnal investigational Site in Lyon
Lyon, 69677
FranceSite Not Available
Diurnal Investigational Site in Paris
Paris, 75651
FranceSite Not Available
Diurnal Investigational Site in Pessac
Pessac, 33604
FranceSite Not Available
Diurnal Investigational Site in Toulouse
Toulouse, 31059
FranceSite Not Available
Diurnal Investigational Site in Toulouse (Children's hospital)
Toulouse, 31059
FranceSite Not Available
Diurnal Investigational Site in Asahi-ku
Yokohama-shi, Kanagawa 241-0811
JapanSite Not Available
Diurnal Investigational Site in Yushima
Bunkyō-Ku, Tokyo 113-8519
JapanSite Not Available
Diurnal Investigational Site in Okura
Setagaya-Ku, Tokyo 157-8535
JapanSite Not Available
Diurnal Investigational Site in Toyama
Shinjuku-Ku, Tokyo 162-8655
JapanSite Not Available
Diurnal Investigational Site in California
Los Angeles, California 90027
United StatesSite Not Available
Diurnal Investigational Site in California
Orange, California 92868
United StatesSite Not Available
Diurnal Investigational Site in Florida
Jacksonville, Florida 32207
United StatesSite Not Available
Diurnal Investigational Site in Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
National Institutes of Health Center
Bethesda, Maryland 20892-1932
United StatesSite Not Available
Diurnal Investigational Site in Michigan
Ann Arbor, Michigan 48114
United StatesSite Not Available
Diurnal Investigational Site in Minnesota
Rochester, Minnesota 55901
United StatesSite Not Available
Diurnal Investigational Site in Nevada
Las Vegas, Nevada 89148
United StatesSite Not Available
Diurnal Investigational Site in Texas
Dallas, Texas 75235
United StatesSite Not Available
Diurnal Investigational Site in Washington
Seattle, Washington 98105
United StatesSite Not Available
Diurnal Investigational Site in Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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