Clinical Trial: Management of Cervical Intraepithelial Neoplasia Grade 2

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Management of Cervical Intraepithelial Neoplasia Grade 2

Brief 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 Summary:

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.

Sponsor: Universidade Cidade de Sao Paulo

Current Primary Outcome: 43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9% [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universidade Cidade de Sao Paulo

Dates:
Date Received: August 7, 2008
Date Started: March 2003
Date Completion:
Last Updated: January 8, 2010
Last Verified: August 2008