Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

8 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Dispositivo: Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.
Placebo.
Comparatore placebo: 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.
Altro: Placebo.
placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Vaginal Health Index (VHI) score.
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Vaginal pH
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

ROELMI HPC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

9 luglio 2026

Completamento primario (Stimato)

30 novembre 2026

Completamento dello studio (Stimato)

30 novembre 2026

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ROVUL-25
  • 44042-44053-44057-44082 (Altro identificatore: Italian Health Ministry)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Russia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi