DEXAMETHASONE for Congenital adrenal hyperplasia|Congenital adrenal hyperplasia - virilising form

Inclusion criteria

• {"criterion_text":"-Adult pregnant females with risk of classic CAH in their fetuses (genetic mutations in both parents)"}
• {"criterion_text":"-Written informed consent of the pregnant mother and the legal guardians of the unborn child"}
• {"criterion_text":"-GW <8+0 post menstruationem"}

Exclusion criteria

• {"criterion_text":"-Co-morbid condition requiring daily administration of a medication (or use of any medications/supplements) that interferes with the metabolism of glucocorticoids"}
• {"criterion_text":"-Clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the upper limit of normal (ULN) or elevated liver function tests (ALT or AST >2 times ULN])"}
• {"criterion_text":"-Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication other than therapy of CAH in the fetus or in the CAH affected mother herself"}
• {"criterion_text":"-History of malignancy (other than basal cell carcinoma successfully treated)"}
• {"criterion_text":"-Participation in a clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study."}
• {"criterion_text":"-Body weight <50 kg or >95 kg before pregnancy"}
• {"criterion_text":"-Subjects unable to comply with the requirements of the protocol"}
• {"criterion_text":"-Pregnancy with twins or multiples"}

Primary endpoints

• {"endpoint_text":"-Closure of urogenital sinus (Prader stage)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Gestational weight gain (GWG) of mother","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"-Parameters of treatment consequences/safety in treated mothers and children","definition_or_measurement_approach":""}
• {"endpoint_text":"-safety parameters: stillbirths, miscarriages, maternal side effects and adverse events, serious adverse events (AEs, SAEs) in treated mothers and children, maternal quality of life, maternal mental health and sleep, child´s birth weight and height at birth, week of gestation at birth, infant nervous system development, malformations in the child)","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

06-11-2024

Latest Decision Or Authorization Date

02-12-2025

Processing Time Days

391

Number Of Sites

2

Number Of Participants

122

Primary sponsor

Full Name

Philipps-Universitaet Marburg

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Universitaetsklinikum Erlangen AöR","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Ludwig-Maximilians-Universitaet Muenchen","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"Freie Universitaet Berlin","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"Eurofins Humangenetik und Praenatal-Medizin MVZ GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}