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Clinical Trials/NL-OMON44944
NL-OMON44944
Recruiting
Phase 3

A randomized, single blinded trial to evaluate the efficacy of Imiquimod in women with residual/recurrent Cervical Intraepithelial Neoplasia (CIN) after previous treatment - TOPIC-2

Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites433 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
433
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Histologically proven CIN2 or CIN 3, without invasion after previous surgical treatment at least 6 months before diagnosis
  • •\- Histologically proven persistent CIN 1 after previous surigcal treament at least 6 months before diagnosis. Persistent CIN 1 is defined as CIN 1 at least persistent for 6 months and proven with histology
  • •\- The patient is willing to use a medically acceptable method of contraception throughout the study
  • •\- Women older than 18 years of age

Exclusion Criteria

  • •\- Pregnancy or lactation
  • •\- (Micro\-)invasive carcinoma
  • •\- Past history of cervical cancer
  • •\- Hypersensitivity of any components of the formulation
  • •\- History of psoriasis or other inflammatory dermatosis of the vulva
  • •\- Immunodeficiency or treatment with immunosuppressive medication
  • •\- Insufficient understanding of the Dutch or English language

Outcomes

Primary Outcomes

Not specified

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