Objective: To analyze the course of p16/Ki-67-positive abnormal cytological cervical findings and high risk (hr)-HPV- and p16/Ki-67-clearances in women treated with a vaginal gel. Methods: 172 women with a histological diagnosis of CIN2 or p16-positive CIN1 lesions were selected based on a positive cytological p16/Ki-67 test. For 3 months, 75 patients in the active arm (AA) daily administered 5 ml of a vaginal gel. Ninety seven patients in the control arm (CA) underwent no treatment ("watchful waiting"). Endpoints were cytological evolution, p16/Ki-67- and hr-HPV-clearances. Results: At 3 months, cytological regression was observed in 76% (57/75) of patients in the AA compared with 25% (24/97) in the CA. Progression occurred in 5% (4/75) of the AA compared with 15% (15/97) of the CA. The p16/Ki-67 status change was statistically significantly (p < 0.001) in favor of the AA: 77% (58/75) became negative compared to 21% (20/97) in the CA. hr-HPV prevalence decreased significantly (p < 0.001) in the AA from 87 to 44%, while increasing in the CA from 78 to 84%. Cytological regression and p16/Ki-67 changes persisted in the AA at 6 months. Conclusions: The vaginal gel significantly cleared hr-HPV and p16/Ki-67 and was associated with improved cytological findings, thereby potentially offering an effective option against oncogenic risk. Clinical Trial Registration: Identifier: [ISRCTN11009040].

Camara and Partners Consultancy Nyon Switzerland

Centrum ambulantní gynekologie a primární péče s r o Brno Czechia

Department of Obstetrics and Gynaecology Cantonal Hospital University of Fribourg Fribourg Switzerland

Department of Obstetrics and Gynaecology Fakultní nemocnice v Motole Onkogynekologická a kolposkopická ambulance Praha Czechia

Department of Obstetrics and Gynaecology University Hospital of Geneva Geneva Switzerland

Femina Gynaecology Centre Geneva Switzerland

G CENTRUM Olomouc s r o Olomouc Czechia

Gyneko spol s r o Vsetin Czechia

Phidalsa Pharma Consultants Geneva Switzerland

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