NCT00941252

Brief Summary

The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. Imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

1.5 years

First QC Date

July 16, 2009

Last Update Submit

January 21, 2011

Conditions

Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

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

    20 weeks after treatment start

Secondary Outcomes (1)

  • HPV-Clearance, feasibility and adverse event profile and drop-out rate

    20 weeks after treatment start

Study Arms (2)

Imiquimod

ACTIVE COMPARATOR

topical therapy for 16 weeks with imiquimod containing therapy

Drug: Topical imiquimod therapy

Placebo

PLACEBO COMPARATOR

topical therapy for 16 weeks with a placebo containing vaginal suppository

Drug: Topical imiquimod therapy

Interventions

Topical imiquimod therapyDRUG

therapy consists of treatment with topical vaginal suppositories for 16 weeks, each vaginal suppository contains 6.25mg of imiquimod, frequency (one time a week in treatment week 1+2, two times a week in treatment week 3+4, three times a week in treatment week 5-16)

Also known as: Aldara
ImiquimodPlacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women who are pregnant or lactating or become pregnant during the conduct of the study
  • 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 structure
  • Participating in another clinical trial within 30 days
  • Malignancy
  • Immunosuppression (medication, illness)
  • HIV- or Hepatitis infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology

Vienna, 1090, Austria

Location

Related Publications (1)

  • Grimm C, Polterauer S, Natter C, Rahhal J, Hefler L, Tempfer CB, Heinze G, Stary G, Reinthaller A, Speiser P. Treatment of cervical intraepithelial neoplasia with topical imiquimod: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.

    PMID: 22914404DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Paul Speiser, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2009

First Posted

July 17, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

AU(1)