Not Yet RecruitingNot Applicable

MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)

182 participantsStarted 2026-03-01

Plain-language summary

MODUCIN-1 (MODUcare for CIN1) is a prospective, single center, open-label, randomized trial that its purpose is to compare MODUCARE versus Wait-and-See Approach for the regression rate of histologically proven low-grade Cervical Intraepithelial Neoplasia (CIN1).

Who can participate

Age range18 Years – 85 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically proven CIN1 * Any HPV status (negative, positive: high or low risk) * Any Pap test result * Age 18 - 85 years old * ECOG Performance status 0 - 1 Exclusion Criteria: * Pregnancy * Low likelihood of patient compliance to treatment protocol and follow-up * Previous operation to the cervix * Previous pelvic malignancy * Pre-existing histologically proven CIN1 \> 12 months * Pre-existing histologically proven CIN2 and/or CIN3 * Hypersensitivity to trial medication

What they're measuring

Regression rate of CIN1

Timeframe: 6 months after randomization

Trial details

NCT IDNCT07379905

SponsorAristotle University Of Thessaloniki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

Contact for this trial

Dimitrios Zouzoulas, MD, MSc, PhD

+306946536065 dzouzoulas@hotmail.gr

View on ClinicalTrials.gov More Low-grade Cervical Intraepithelial Neoplasia trials