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Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25). (ROVUL-25)

8. juli 2026 opdateret af: ROELMI HPC

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.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: INTIMIQUE OVULI
Participants receive INTIMIQUE OVULI vaginal ovules administered according to the three treatment cycles (7+4+3 days), in addition to the elective antibacterial or antifungal pharmacological treatment for their diagnosis (BV or VVC).
Enhed: Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.
Placebo.
Placebo komparator: PLACEBO
Participants receive placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate), identical in appearance and packaging to the active device, administered according to the same schedule, in addition to the elective antibacterial or antifungal pharmacological treatment.
Andet: Placebo.
placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Vaginal Health Index (VHI) score.
Tidsramme: 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).
Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vaginal pH
Tidsramme: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days)
Vaginal pH measured by rapid semiquantitative dry chemical method.
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
Tidsramme: 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 (itching, burning, pain) via Visual Analog Scale (VAS 0-10) using daily diary.
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
Tidsramme: 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 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)
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
Tidsramme: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
All treatment-related adverse reactions (mild, moderate, severe) over the three treatment phases (7+4+3 days) will be recorded.
Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ROELMI HPC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

9. juli 2026

Primær færdiggørelse (Anslået)

30. november 2026

Studieafslutning (Anslået)

30. november 2026

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ROVUL-25
  • 44042-44053-44057-44082 (Anden identifikator: Italian Health Ministry)

Plan for individuelle deltagerdata (IPD)

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