Status:
COMPLETED
A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
21-hydroxylase Deficiency
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 c...
Detailed Description
This is a non-randomized (patients will not be assigned by chance to study treatments), open-label (patients will know the identity of study treatments), multiple-dose, intra-patient sequential dose-e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01495910
Start Date
December 1 2011
End Date
February 1 2013
Last Update
February 28 2014
Active Locations (3)
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1
Chicago, Illinois, United States
2
Ann Arbor, Michigan, United States
3
Dallas, Texas, United States