Cancer
Conditions
Interventions
Topical 5 Fluorouracil and Imiquimod Cream
Sponsors
College of Medicine University of Lagos
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Sexually active women Age 30–65 years Diagnosed with high-grade CIN lesions (CIN 2 or CIN 3) confirmed by colposcopic biopsy after positive cervical cytology and/or high-risk HPV testing Women free from any mental or physical disabilities that inhibit them from understanding the implications of the study Those not considering relocating from their current residence within the next year.
Exclusion criteria
Exclusion criteria: suspicious cervical lesions, concomitant vulvar and/or vaginal intraepithelial neoplasia, immunodeficiency, Current pregnancy or within 6 weeks of childbirth Previous hysterectomy, or history of cervical cancer or therapy for benign or malignant cervical lesions Current malignant disease Refusal of consent at enrolment Inability to self-collect adverse event data using the symptom diary or a visual analogue scale (VAS)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The rate of reversal of cervical cytological abnormalities;The rate of high-risk human papillomavirus (HR-HPV) clearance;The rate of adverse event (safety) profiles;The rate of CIN2/3 recurrence | — |
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants achieving complete regression of CIN2/3 lesions, defined as negative colposcopy and biopsy findings, at 3 months post-treatment initiation between treatment arms | — |
Countries
Nigeria
Contacts
Public ContactKehinde Okunade
Associate Professor of Obstetrics and Gynaecology
Outcome results
None listed