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drugset / Trial / NCT01495910

A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency

NCT01495910 ↗

Phase 1 Completed 6 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the minimum dose of abiraterone acetate needed to decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid replacement for classic 21-hydroxylase deficiency.

Timeline

Start
2011-12
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 100 mg Oral
Subject Abiraterone acetate Small molecule 250 mg Oral
Subject Abiraterone acetate Small molecule 500 mg Oral

Indications

classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency