Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorROELMI HPC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Female sex
Age 18 to 60 years
Able to understand and sign informed consent
Able to understand and comply with protocol requirements
Disqualifiers
Male sex
Age < 18 or > 60 years
Pregnant, suspected pregnant, or planning pregnancy during the study period
Breastfeeding
Trial design
Design model
Parallel
Treatments tested in this trial
Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.
DevicePlacebo.
Placebo.
Other interventionplacebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate)
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: INTIMIQUE OVULIExperimental treatment 1 intervention
Group B: PLACEBOPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Vaginal Health Index (VHI) score.
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).
Time frame
Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).Secondary outcomes
1
Vaginal pH
Vaginal pH measured by rapid semiquantitative dry chemical method.
Time frame
Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days)2
Subjective symptoms
Subjective symptoms (itching, burning, pain) via Visual Analog Scale (VAS 0-10) using daily diary.
Time frame
Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).3
Quality of life SF-12
Quality of life short form questionnaire SF-12 (5 domains: sleep quality, daily activities, emotional wellbeing, sexual activity, social interactions; 0-10 scale each, referring to the previous 7 days)
Time frame
Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).4
Tollerability
All treatment-related adverse reactions (mild, moderate, severe) over the three treatment phases (7+4+3 days) will be recorded.
Time frame
Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days). Source ClinicalTrials.gov
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