SYF22d858c94f4e4514b1a62b1f28b9e671Registry ID: 2024-511702-23-00|RecruitingPhase 2
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interventional
N/A
1 country
2
To investigate if a reduced dexamethasone dose is effective and non-inferior to the currently experimentally used high (“standard”) dose regimen in preventing prenatal virilization in females with classic congenital adrenal hyperplasia (CAH) and to investigate the effect on maternal weight gain during gestation (GWG)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 5, 2024
Actual (reported)Closure of urogenital sinus (Prader stage)
Gestational weight gain (GWG) of mother
Parameters of treatment consequences/safety in treated mothers and children
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)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Dexamethason 0.15mg
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
Dexamethason 0.21mg
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
Dexamethason 0.41mg
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
Dexamethason 0.5mg
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Dexamethason 0.15mg
Named ingredient: Dexamethasone
View registry recordDexamethason 0.21mg
Named ingredient: Dexamethasone
View registry recordDexamethason 0.41mg
Named ingredient: Dexamethasone
View registry recordDexamethason 0.5mg
Named ingredient: Dexamethasone
View registry recordKlinikum der Universitaet Muenchen AöR
Munich, 80336, Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, 13353, Germany
KKS Marburg
First Submitted
September 5, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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