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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)


Phase 1
18 Years
50 Years
Not Enrolling
Female
Uterine Cervical Neoplasms, Cervix Intraepithelial Neoplasia

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

adverse events

Outcome Time Frame:

weeks 1, 2, 3 and 4

Safety Issue:

Yes

Principal Investigator

Michel Bossens, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Erasme Hospital - Laboratoire de recherche en reproduction humaine

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

MI-COL-CI01

NCT ID:

NCT00989443

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Uterine Cervical Neoplasms
  • Cervix Intraepithelial Neoplasia
  • Cervix Intraepithelial Neoplasia grades 2 and 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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