NCT01283763

Brief Summary

The purpose of this study is to investigate the non-inferiority of a topical Imiquimod therapy in patients with persistent CIN 2/3 when compared to standard therapy, i.e. conization A randomized, controlled, non-inferiority AGO-Austria trial

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
95

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
2.3 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

4.3 years

First QC Date

January 21, 2011

Last Update Submit

October 30, 2016

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Cervical Intraepithelial Neoplasia, Imiquimod, conization

Outcome Measures

Primary Outcomes (1)

  • HPV clearance

    non-inferiority of experimental treatment (Imiquimod) to active control (conization)

    6 months after treatment completion

Secondary Outcomes (2)

  • Rates of CIN remission/regression and/or CIN persistence/regression after treatment

    6, 12, and 24 months after treatment completion

  • HPV clearance

    12 and 24 months after treatment completion

Study Arms (2)

Topical Imiquimod

EXPERIMENTAL

16 weeks topical Imiquimod

Drug: Topical Imiquimod

Conization

ACTIVE COMPARATOR

Large loop excision of the transformation zone

Procedure: Conization

Interventions

Topical ImiquimodDRUG

16 weeks

Also known as: Aldara®
Topical Imiquimod
ConizationPROCEDURE

Large loop excision of the transformation zone

Conization

Eligibility Criteria

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

You may qualify if:

  • Women aged ≥18 years diagnosed with histologically verified CIN 3 and women aged ≥ 30 years diagnosed with CIN 2
  • Satisfactory colposcopy
  • Signed informed consent
  • Negative pregnancy test
  • Appropriate contraception method for fertile women during active study period
  • Adequate compliance

You may not qualify if:

  • Adenocarcinoma in situ
  • History of previous conization
  • Colposcopy suspicious for invasive disease
  • Pregnancy and lactation period
  • Known allergy or intolerance to IMQ
  • Contraindications to conization or IMQ
  • Symptoms of a clinically relevant disease
  • Known HIV infection
  • Evidence of a clinically significant immunodeficiency
  • Current, reported participation in another experimental, interventional protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria, 1090, Austria

Location

Related Publications (1)

  • Polterauer S, Reich O, Widschwendter A, Hadjari L, Bogner G, Reinthaller A, Joura E, Trutnovsky G, Ciresa-Koenig A, Ganhoer-Schimboeck J, Boehm I, Berger R, Langthaler E, Aberle SW, Heinze G, Gleiss A, Grimm C. Topical imiquimod compared with conization to treat cervical high-grade squamous intraepithelial lesions: Multicenter, randomized controlled trial. Gynecol Oncol. 2022 Apr;165(1):23-29. doi: 10.1016/j.ygyno.2022.01.033. Epub 2022 Feb 15.

    PMID: 35177279DERIVED

Related Links

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

ImiquimodConization

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 CompoundsBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Stephan Polterauer, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

  • Stephan Polterauer, MD

    Medical University of Vienna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof. MD

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 26, 2011

Study Start

May 1, 2013

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

AU(1)