CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 13 enrolled
Drug / intervention
Imiquimod +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03196180
NCT03196180Early Ph 1Completed
CompareCT.gov

A Feasibility Trial of Alternating Intravaginal Application of 5-Fluorouracil and Imiquimod for Treatment of High-Grade Cervical Squamous Intraepithelial Lesions

National Cancer Institute (NCI)·interventional·Posted Jun 22, 2017·Updated Apr 8, 2025

In Brief

A Early Phase 1 clinical trial evaluating Imiquimod and Topical Fluorouracil for Cervical Intraepithelial Neoplasia Grade 2/3 and 3 related conditions. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This early phase I clinical trial studies the side effects of topical fluorouracil and imiquimod ointment in treating patients with high-grade cervical intraepithelial neoplasia. Topical fluorouracil may kill precancerous cells. Imiquimod ointment may stimulate the immune system. Applying topical fluorouracil and imiquimod ointment may cause fewer side effects and may be a better way to treat patients with precancerous cervical lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Intraepithelial Neoplasia Grade 2/3, Cervical Squamous Cell Carcinoma In Situ, Cervical Squamous Intraepithelial Neoplasia 2, High Grade Cervical Intraepithelial Neoplasia
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 22, 2017
Enrollment StartOct 15, 2019
Primary CompletionNov 4, 2020
Study CompletionAug 2, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.0 years ago

Interventions

Imiquimoddrug

Given intravaginally

Topical Fluorouracildrug

Given intravaginally