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Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia

Phase 2/Phase 3
18 Years
80 Years
Not Enrolling
Cervical Intraepithelial Neoplasia

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Trial Information

Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia

Inclusion Criteria:

- Caucasian women aged 18 years and older with proven HPV-associated CIN 2/3

- Colposcopy with fully visible transformation zone and lesion

- Safe Contraception

- Signed Informed Consent

- Negative urine pregnancy test

- Able to communicate well with the investigator, to understand and comply with the
requirements of the study

- Signed the written informed consent

Exclusion Criteria:

- Women who are pregnant or lactating or become pregnant during the conduct of the

- Symptoms of a clinically relevant illness in the 3 weeks before the first study day

- History of hypersensitivity to the trial drug or to drugs with a similar chemical

- Participating in another clinical trial within 30 days

- Malignancy

- Immunosuppression (medication, illness)

- HIV- or Hepatitis infection

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3

Outcome Time Frame:

20 weeks after treatment start

Safety Issue:


Principal Investigator

Paul Speiser, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna


Austria: Austrian Agency for Health and Food Safety

Study ID:




Start Date:

July 2009

Completion Date:

January 2011

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ