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Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).

NCT07703241 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-14

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, two-arm parallel-group clinical study evaluating the efficacy and safety of INTIMIQUE OVULI, a Class IIa vaginal medical device, in adult women (18-60 years) diagnosed with bacterial vaginosis (BV) or vulvovaginal candidiasis (VVC). Participants are randomized 1:1 to receive the active device or a placebo ovule, in addition to standard-of-care antibacterial or antifungal pharmacological treatment, depending on diagnosis. Treatment is administered in three cycles (7 consecutive days, then 4 consecutive days, then 3 consecutive days, each separated by washout periods), followed by a 2-month follow-up. The study is a post-market clinical investigation conducted as part of the device's transition from MDD to MDR.

Conditions

  • Bacterial Vaginosis
  • Candidal Vaginitis

Interventions

DEVICE

Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.

Placebo.

OTHER

Placebo.

placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate)

Sponsors & Collaborators

  • ROELMI HPC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-09
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703241 on ClinicalTrials.gov