Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00989443
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : October 21, 2010
Information provided by:
Mithra Pharmaceuticals

Brief Summary:

Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.

This clinical study is aimed at :

  1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions;
  2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Cervix Intraepithelial Neoplasia Drug: Cidofovir gel Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study to Evaluate the Tolerance and Safety of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesion(s) (CIN 2 and 3)
Study Start Date : May 2010
Actual Primary Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cidofovir

Arm Intervention/treatment
Experimental: Cidofovir Drug: Cidofovir gel
topical gel applied once a week for 3 weeks

Primary Outcome Measures :
  1. adverse events [ Time Frame: weeks 1, 2, 3 and 4 ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • women aged between 18 and 50 years old
  • volunteers
  • informed consent signed
  • cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks
  • no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring)

Exclusion Criteria:

  • pregnancy or breast feeding
  • subtotal hysterectomy
  • current or ancient renal impairment
  • current immune disorder
  • current use of drugs interfering with renal function
  • current treatment for any cancer
  • current use of treatment interfering with immunity
  • current use of anti-viral treatment
  • current or recent participation to another experimental study during the last 3 months before the screening visit
  • current vaginal application of drugs or cosmetics
  • local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00989443

Erasme Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Mithra Pharmaceuticals
Principal Investigator: Michel Bossens, MD, PhD Erasme Hospital - Laboratoire de recherche en reproduction humaine

Responsible Party: Dr. Michel Bossens, Erasme Hospital Identifier: NCT00989443     History of Changes
Other Study ID Numbers: MI-COL-CI01
First Posted: October 5, 2009    Key Record Dates
Last Update Posted: October 21, 2010
Last Verified: October 2010

Keywords provided by Mithra Pharmaceuticals:
Cervix Intraepithelial Neoplasia grades 2 and 3

Additional relevant MeSH terms:
Carcinoma in Situ
Uterine Cervical Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Dysplasia
Precancerous Conditions
Antiviral Agents
Anti-Infective Agents