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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Bacterial Vaginosis, Candidal Vaginitis

In brief

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.

Key facts

Study ID

NCT07703241

Run by

ROELMI HPC

People needed

80

Starts

2026-07-09

Expected to finish

2026-11-30

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female sex
• Age 18 to 60 years
• Able to understand and sign informed consent
• Able to understand and comply with protocol requirements
• Negative pregnancy test
• Negative HIV test
• Not taking, and agreeing not to take, any other medication or medical device for the duration of the study, except the elective antibacterial or antifungal treatment for BV or VVC
• Presenting symptoms suggestive of BV or VVC at screening (leukorrhea, itching, burning)
• Confirmed clinical diagnosis of bacterial vaginosis (yellow-green or gray vaginal discharge; vaginal pH > 4.5; positive whiff test/fishy odor with potassium hydroxide), OR
• Confirmed clinical diagnosis of vulvovaginal candidiasis (gynecological examination with itching, burning, thick white discharge; vaginal pH typically < 4.5; vaginal swab confirmation of *Candida* spp.)

You may not qualify if…

• Male sex
• Age < 18 or > 60 years
• Pregnant, suspected pregnant, or planning pregnancy during the study period
• Breastfeeding
• Not self-sufficient
• Unwilling/unable to cooperate with study procedures
• Unable to attend the study site within the required timeframe
• Judged unsuitable by the investigator due to other conditions incompatible with enrollment requiring pharmacological treatment
• HIV-positive / acquired immunodeficiency
• Known allergy to components of the investigational products (active or placebo)
• Presence of vaginal infections other than BV or VVC
• Alcohol, drug, nicotine, or excessive caffeine/theine abuse
• Use of vaginal or systemic antifungal/antibiotic treatment within the 7 days prior to enrollment
• Taking any other medication or medical device during the study period, except the elective treatment for BV/VVC*
• Systemic or immunosuppressive conditions interfering with symptom interpretation
• Participation in another clinical study within the previous 30 days
• If pharmacological treatment becomes necessary, this must be reported to the Principal Investigator, who will assess on a case-by-case basis whether the subject should be excluded.

Where it is running

• Clinica Mediterranea — Naples, Italy

Full record on ClinicalTrials.gov

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