We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989443
First Posted: October 5, 2009
Last Update Posted: October 21, 2010
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.
Information provided by:
Mithra Pharmaceuticals
  Purpose

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 Intervention Phase
Uterine Cervical Neoplasms Cervix Intraepithelial Neoplasia Drug: Cidofovir gel Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Mithra Pharmaceuticals:

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

Estimated Enrollment: 6
Study Start Date: May 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cidofovir Drug: Cidofovir gel
topical gel applied once a week for 3 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00989443


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

Responsible Party: Dr. Michel Bossens, Erasme Hospital
ClinicalTrials.gov Identifier: NCT00989443     History of Changes
Other Study ID Numbers: MI-COL-CI01
EudraCT2009-012937-31
First Submitted: October 2, 2009
First Posted: October 5, 2009
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:
Neoplasms
Carcinoma in Situ
Uterine Cervical Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Cervical Intraepithelial Neoplasia
Carcinoma
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
Cidofovir
Antiviral Agents
Anti-Infective Agents