Brief Title
Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
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)
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
adverse events
Condition
Uterine Cervical Neoplasms
Intervention
Cidofovir gel
Study Arms / Comparison Groups
Cidofovir
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
6
Start Date
May 2010
Primary Completion Date
September 2010
Eligibility 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
Gender
Female
Ages
18 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Michel Bossens, MD, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00989443
Organization ID
MI-COL-CI01
Secondary IDs
EudraCT2009-012937-31
Study Sponsor
Mithra Pharmaceuticals
Study Sponsor
Michel Bossens, MD, PhD, Principal Investigator, Erasme Hospital - Laboratoire de recherche en reproduction humaine
Verification Date
October 2010