9 CIS RETINOIC ACID IN CERVICAL INTRAEPITHELIAL NEOPLASIA GRADE 2 &3

$29,529M01FY2000RRNIH

University Of Alabama At Birmingham, Birmingham AL

Investigators

Linked publications & trials

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Abstract

This is a phase II trial of 9-cis retinoic acid (9-CRA) in patients with CIN 2/3. Patients undergo initial medical evaluation, colposcopy and biopsy, and laboratory assessment of organ function. Eligible patiens are then randomized in a double-blind fashion to placebo, low dose 9-CRA or high dose 9-CRA for a period of 12 weeks. At the completion of study medicaitons, all patients undergo loop excision of the cervical transformation zone. Study endpoints include evaluation of compliance, assessment of clinical and laboratory side effects of study medication, analysis of pharmacokinetics of study medication (in a subset of study population), evaluation for alteration of cervical dysplasia histology, and assessment of alteration of surrogate endpoint biomarkers.

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