CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Celecoxib +2 moredrug
Likely dose
Celecoxib dose not specified in available textAI-extracted
Key inclusion· 6
  • ✓Histologically proven CIN 2/3 or CIN 3 diagnosed by cervical biopsy 2-8 weeks prior to enrollment
  • ✓Satisfactory (readable, good quality) colposcopic evaluation at least 14 days after diagnostic biopsy
  • ✓Colposcopically visible cervical lesion at entry consistent with biopsy
  • ✓Negative urine pregnancy test; women of childbearing potential must practice acceptable contraception
Key exclusion· 11
  • ✕Pregnant or lactating
  • ✕Cytologic or biopsy evidence of endocervical dysplasia or invasive cancer
  • ✕Undiagnosed abnormal vaginal bleeding
  • ✕Previous celecoxib or COX-2 inhibitor use >3 times per week within 60 days prior to randomization

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

Search/NCT00081263
NCT00081263Phase 2Completed
CompareCT.gov

A Randomized Double-Blind Phase II Trial of Celecoxib, A COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or 3)

Gynecologic Oncology Group·interventional·Posted Apr 8, 2004·Updated Sep 15, 2017

In Brief

A Phase 2 clinical trial evaluating Celecoxib, Laboratory Biomarker Analysis, and 1 other intervention for Cervical Carcinoma and 2 related conditions. Completed, enrolled 130 participants across 43 sites.

Detailed Summary

This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3, Stage 0 Cervical Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 8, 2004
Enrollment StartJun 1, 2005
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 22.2 years ago

Interventions

Celecoxibdrug

Given orally

Laboratory Biomarker Analysisother

Correlative studies

Placeboother

Given orally