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

NCT07379905 | Not Yet Recruiting

• 1 other identifier: 2025-Β2015-518
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Low-grade Cervical Intraepithelial Neoplasia; Moducare

Outcome Measures

Primary Outcomes (1)

• Regression rate of CIN1

  6 months after randomization

Secondary Outcomes (3)

• Regression rate of CIN1

  12 months after randomization

• Progression rate of CIN1

  6 & 12 months after randomization

• Treatment related adverse events

  : 6 months after randomization

Study Arms (2)

ARM A: Control Arm

NO INTERVENTION

Wait-and-See approach

ARM B: Intervention Arm

EXPERIMENTAL

MODUCARE oral capsules., dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer)

Dietary Supplement: MODUCARE

Interventions

MODUCARE DIETARY_SUPPLEMENT

MODUCARE is classified as a natural dietary supplement, specifically an immune support supplement containing a patented blend of plant sterols and sterolins, primarily beta-sitosterol and beta-sitosterol glucoside, derived from plant sources.

ARM B: Intervention Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• INPA S.A.: collaborator

Study Officials

• Dimitrios Tsolakidis, Dr.Prof.

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Zouzoulas, MD, MSc, PhD

CONTACT

+306946536065; dzouzoulas@hotmail.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecological Oncologist, MSc, PhD, FEBS-BS

Model Details: * ARM A: Control Arm for Wait-and-See approach * ARM B: Intervation Arm for MODUCARE oral capsules, dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer)

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share