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

Completed · Phase 1

Conditions studied: 21-hydroxylase Deficiency

In brief

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.

Key facts

Study ID

NCT01495910

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

6

Starts

2011-12-01

Expected to finish

2013-02-01

Last updated by the study team

2014-02-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Premenopausal women >=18 years of age.
• Must be receiving a hormonal contraceptive agent containing both estrogen and progesterone.
• Confirmed 21-hydroxylase deficiency by CYP21A2 genotype associated with classic congenital adrenal hyperplasia.
• Demonstrates a >=1.5 X ULN of morning serum androstenedione concentration while taking study-defined doses of hydrocortisone and fludrocortisone.
• No coexisting medical conditions in the opinion of the investigator that would preclude participation in the study.

You may not qualify if…

• Current or history of active or chronic hepatitis, including symptomatic viral hepatitis A, B, or C.
• Any active infection.
• Evidence of active malignancy.
• Serious or uncontrolled co-existent non-malignant disease.
• Receiving systemic glucocorticoids for any reason other than for the treatment of 21-hydroxylase deficiency.
• Any disorders that require treatment with anticonvulsants.
• Patients of child-bearing potential who are not willing to use a method of birth control during the study and for 3 months after the end-of-study.
• Women who are pregnant or breast-feeding.
• Genotypes associated with non-classic congenital adrenal hyperplasia.

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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