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Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).
Condition(s) studied
Bacterial VaginosisCandidal Vaginitis
Investigational drug(s) / intervention(s)
Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.Placebo.
Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.: Placebo.
Placebo.: placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate)
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.
Eligibility
Inclusion Criteria:
* 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.)
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Change in Vaginal Health Index (VHI) score. — Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
Composite score assessed by the investigator across 5 clinical parameters (vaginal elasticity, vaginal secretions, pH, epithelium, moisture), each scored 1-5 (total range 5-25).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Clinica Mediterranea |
Naples |
Italy |
|
