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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00733109
Other study ID # CIN 2
Secondary ID
Status Completed
Phase Phase 4
First received August 7, 2008
Last updated January 8, 2010
Start date March 2003
Est. completion date July 2007

Study information

Verified date August 2008
Source Universidade Cidade de Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 2007
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 61 Years
Eligibility Inclusion Criteria:

- Histological CIN2 diagnosis

Exclusion Criteria:

- Previous CIN treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Brazil Leonor Mendes de Barros Maternity Hospital São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Universidade Cidade de Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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% 12 months Yes
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