NCT01303328

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

9 active sites

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

First Submitted

Initial submission to the registry

February 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 18, 2013

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

February 18, 2011

Last Update Submit

February 15, 2013

Conditions

Uterine Cervical NeoplasiaCervix Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (3)

  • Efficacy at week 12: change of histological and cytological parameters (success or not)

    Efficacy will be measured by histological and cytological criteria at week 12 (disappearance of CIN 2+) in correlation with viral status (positive or negative) before and after treatment.

    12 weeks

  • Efficacy at week 28: recurrence rate

    The recurrence rate will be assessed at week 28, by the same histological and cytological criteria in correlation with the viral status (positive or negative) before and after treatment.

    28 weeks

  • Tolerance and Safety (AE reporting, changes of gynecological and biological parameters)

    Safety will be measured by record of adverse events, changes in clinical biology test results; local tolerance will be measured by patient questioning and gynecological examination of vagina and cervix.

    during 30 weeks

Secondary Outcomes (2)

  • Virological status (infection)

    during 30 weeks

  • Changes in lesion (colposcopic changes)

    during 30 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL
Drug: C1

Placebo group

PLACEBO COMPARATOR
Drug: C1

Interventions

C1DRUG

Local application of the experimental gel or placebo gel.

Placebo groupTreatment group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged between 18 and 50 years old
  • Informed consent signed

You may not qualify if:

  • Invasive or microinvasive cervical neoplasia
  • Pregnancy or breast feeding
  • Subtotal hysterectomy
  • Current renal impairment
  • Current immune disorder including serology HIV +
  • Current use of drugs interfering with renal function
  • Current use of oncologic treatment
  • Current use of immune treatment
  • Current use of anti-viral treatment
  • Current vaginal application of drugs or cosmetics
  • Prior treatment with the antiviral on the cervix
  • Local or general condition incompatible with the experimental treatment in the opinion of the principal investigator
  • Current or recent participation to another experimental study during the last 3 months before the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hôpital Saint Pierre

Brussels, Brussels Capital, 1000, Belgium

Location

CHU Brugmann

Brussels, Brussels Capital, 1020, Belgium

Location

Hôpital Erasme

Brussels, Brussels Capital, 1070, Belgium

Location

HIS Ixelles

Ixelles-Elsene, Brussels Capital, 1050, Belgium

Location

CHU Charleroi Hôpital Civil

Charleroi, Charleroi, 6000, Belgium

Location

CHU Charleroi Site André Vésale

Montigny-le-Tilleul, Charleroi, 6110, Belgium

Location

CHU Tivoli

La Louvière, La Louvière, 7100, Belgium

Location

CHU ND des Bruyères

Chênée, Liege, 4032, Belgium

Location

CHR Citadelle

Liège, Liege, 4000, Belgium

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Philippe SIMON, MD, PhD, Professor

    Hôpital Erasme, service de gynécologie obstétrique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 24, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 18, 2013

Record last verified: 2012-08

Locations

BE(9)