Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mithra Pharmaceuticals
• Treatments: Antiviral Agents

Criteria

Inclusion Criteria:

• Women aged between 18 and 50 years old

• Informed consent signed

• Cervical lesion classified CIN 2 or 3, on a biopsy made during the 60 days before inclusion

• No sexual activity, or proved sterility, or use of effective mechanical, hormonal or intrauterine contraception during 30 days following inclusion (except vaginal ring Nuvaring, diaphragm and spermicide)

Exclusion Criteria:

• Invasive or microinvasive cervical neoplasia

• Pregnancy or breast feeding

• Subtotal hysterectomy

• Current renal impairment

• Current immune disorder including serology HIV +

• Current use of drugs interfering with renal function

• Current use of oncologic treatment

• Current use of immune treatment

• Current use of anti-viral treatment

• Current vaginal application of drugs or cosmetics

• Prior treatment with the antiviral on the cervix

• Local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

• Current or recent participation to another experimental study during the last 3 months before the screening visit