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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Abiraterone Acetate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.