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

Official title

Evaluation of the Efficacy and Safety of a Vaginal Ovule Medical Device in the Treatment of Bacterial Vaginosis and Candidal Vaginitis: A Randomized, Placebo-Controlled, Two-Arm Parallel-Group Study.

Overview

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.

Detailed description

INTIMIQUE OVULI is a Class IIa vaginal medical device supplied as vaginal ovules (7 ovules per pack, 2 g each), intended as an adjuvant in the prophylaxis, and prevention of vaginal infections and their recurrence (fungal vaginitis and bacterial vaginosis), and for vaginal environment alterations. Each ovule contains tyndallized Lactobacillus rhamnosus LRH020, sodium hyaluronate, lactic acid, essential oils (Melaleuca alternifolia and white thyme), galactoarabinan, vitamin E acetate, vitamin A palmitate, and semisynthetic triglycerides. The device is intended to restore the vaginal environment and physiological pH, counteract vaginal dryness, and protect the mucosa, reducing irritative symptoms (itching, redness, burning, edema, pain).

Device safety has been previously assessed through preclinical testing: an in vitro cytotoxicity test (NRU assay, ISO 10993-5), a skin sensitization test (Local Lymph Node Assay in mice, ISO 10993-10/OECD TG 429), and a vaginal irritation test in rabbits (ISO 10993-10), all with favorable (non-cytotoxic, non-sensitizing, non-irritant) results.

Clinical diagnosis of BV or VVC will be established at the screening visit based on clinical history, vaginal pH, and characteristics of vaginal discharge, with microbiological confirmation by vaginal swab for VVC. Treatment duration is 7 consecutive days (T-7d), followed by a 3-week washout, a second 4-day treatment, a further washout of 3 weeks and 3 days, a third 3-day treatment, and a 2-month follow-up period (T-112d). Efficacy will be assessed in the overall population and, post-hoc, in the two diagnostic subgroups (BV and VVC).

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)

Primary outcome measures

• Change in Vaginal Health Index (VHI) score. [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 outcome measures (4)

• Vaginal pH [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)]
• Subjective symptoms [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).]
• Quality of life SF-12 [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).]
• Tollerability [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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Italy · 1 center

• Clinica Mediterranea — Naples

Identifiers

NCT: NCT07703241 · ROVUL-25 · 44042-44053-44057-44082

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗