Conditions: Cervical Intraepithelial Neoplasia Uterine Cervical Dysplasia
Keywords: Cervical Intraepithelial Neoplasia (CIN) High-grade Cervical Intraepithelial Neoplasia High-grade Squamous Intraepithelial Lesions (HSIL) Human Papilloma Virus (HPV) High-Grade Cervical Intraepithelial Lesions (CIN 2/3)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 147
Healthy volunteers: no

Brief summary:
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.

Detailed description:
This is a randomized, double-blind, placebo-controlled study. It will randomize patients in a 1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 5 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.

Arms:
arm 1: Placebo administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles. arm 2: 0.25% A007 administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.

Interventions: intervention 1: placebo intervention 2: A007
Intervention descriptions: intervention 1: 5 days of 28 day cycle for 2 cycles intervention 2: 5 days of 28 day cycle

Protocol document: