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Not yet recruiting NCT07379905

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

No phase Interventional Low-grade Cervical Intraepithelial Neoplasia Moducare

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MODUCARE.
Who it may be relevant to
Registry conditions: Low-grade Cervical Intraepithelial Neoplasia, Moducare. Basic parameters: 18 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

Human Papillomavirus (HPV) is causally associated with cervical cancer and precancerous lesions (dysplasias) of the cervix. These lesions are detected mainly in the transformation zone and are diagnosed with colposcopy and biopsy confirmation. In high-grade lesions conization (surgical removal of a cone tissue form the cervix) is the therapy of choice, but in low-grade lesions monitoring and no-treatment is preferred. However, this wait-and-see approach can be assisted by pharmaceutical treatment, like MODUCARE.

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. It is taken orally, 2 capsules three times daily for the first month and then 1 capsule three times daily for next 5 months (in total 6 months).

Interventions

  • Dietary supplement MODUCARE
    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.

Primary outcome measures

  • Regression rate of CIN1 [Time frame: 6 months after randomization]
Secondary outcome measures (3)
  • Regression rate of CIN1 [Time frame: 12 months after randomization]
  • Progression rate of CIN1 [Time frame: 6 & 12 months after randomization]
  • Treatment related adverse events [Time frame: : 6 months after randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Zouzoulas D, Sofianou I, Chatzistamatiou K, Theodoulidis V, Grimbizis G, Tsolakidis D. Comparison of Moducare versus Wait-and-See approach for histologically proven Low-grade Cervical Intraepithelial Neoplasia (CIN1) (MODUCIN1 TRIAL) - Study protocol. PLoS One. 2026 Jul 13;21(7):e0353119. doi: 10.1371/journal.pone.0353119. eCollection 2026. PMID 42441577

Identifiers

NCT: NCT07379905 · 2025-Β2015-518

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗