Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
A Two-Stage Phase 2 Study Of Dose-Intense 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-Hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.
This is a non-randomized, two-stage phase II study with pathological response rate as the
primary objective. Following biopsy confirmation of CIN 2/3 within the last 12 weeks, women
will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients
will apply gel once daily for 14 consecutive days of a 28-day cycle for 2 cycles.
Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and
immunologic testing (see schedule of events in attachment TG-003.01 for visit intervals).
Following the two cycles of treatment with A-007, treating physicians will perform a LEEP at
the month 4 visit. The investigator is responsible for ensuring that the LEEP is conducted
according to the procedures and guidelines of their institution.
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