NCT00733109

Management of Cervical Intraepithelial Neoplasia Grade 2

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Universidade Cidade de Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 61 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.

Detailed description

Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy. The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
PROCEDURE	Excision of the lesion	Surgery with Large Loop Excision of Transformation Zone (LLETZ)
OTHER	Follow-up for spontaneous regression of the lesion	Follow-up at last 12 months

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-07-01
• Completion: 2007-07-01
• First posted: 2008-08-12
• Last updated: 2010-01-11

Locations

1 site across 1 country: Brazil