Status:
COMPLETED
Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
Lead Sponsor:
Mithra Pharmaceuticals
Conditions:
Uterine Cervical Neoplasms
Cervix Intraepithelial Neoplasia
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00989443
Start Date
May 1 2010
Last Update
October 21 2010
Active Locations (1)
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1
Erasme Hospital
Brussels, Belgium, 1070