Clinical trial · Interventional
MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)
A Randomized Trial of MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)
NCT07379905CI-TRIAL-00102599MODUCIN1not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low-grade Cervical Intraepithelial Neoplasia | Low Grade Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Moducare | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MODUCARE | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- ARM A: Control Arm
- description
- Wait-and-See approach
- type
- EXPERIMENTAL
- label
- ARM B: Intervention Arm
- description
- 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)
- interventionNames
- Dietary Supplement: MODUCARE
Primary outcomes (1)
- measure
- Regression rate of CIN1
- timeFrame
- 6 months after randomization
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZouzoulas 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