Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
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)
2 other identifiers
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 5, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedOctober 21, 2010
October 1, 2010
4 months
October 2, 2009
October 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adverse events
weeks 1, 2, 3 and 4
Study Arms (1)
Cidofovir
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasme Hospital
Brussels, 1070, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Bossens, MD, PhD
Erasme Hospital - Laboratoire de recherche en reproduction humaine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 5, 2009
Study Start
May 1, 2010
Primary Completion
September 1, 2010
Last Updated
October 21, 2010
Record last verified: 2010-10