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Management of Cervical Intraepithelial Neoplasia Grade 2

NCT00733109 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-01-11

No results posted yet for this study

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.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

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

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Universidade Cidade de Sao Paulo

    lead OTHER

Principal Investigators

  • Sylvia F Brenna, MD, PhD · Universidade Cidade de Sao Paulo

  • Ana C Guedes, MD, PhD · Universidade Cidade de Sao Paulo

  • Kari J Sirjanen, MD, PhD · University of Turku

  • Luis C Zeferino, MD, PhD · University of Campinas, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
61 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2006-07-31
Completion
2007-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00733109 on ClinicalTrials.gov