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Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)

NCT01303328 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-02-18

No results posted yet for this study

Summary

The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.

Conditions

  • Uterine Cervical Neoplasia
  • Cervix Intraepithelial Neoplasia

Interventions

DRUG

C1

Local application of the experimental gel or placebo gel.

Sponsors & Collaborators

  • Mithra Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Philippe SIMON, MD, PhD, Professor · Hôpital Erasme, service de gynécologie obstétrique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303328 on ClinicalTrials.gov