Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25). (ROVUL-25)
8. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Interventionell
Einschreibung (Geschätzt)
80
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Chiara Trombetta
- Telefonnummer: 00000000000000
- E-Mail: chiara.trombetta@roelmihpc.com
Studienorte
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Naples, Italien, 80122
- Clinica Mediterranea
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Kontakt:
- Agostino Menditto, Dr.
- Telefonnummer: 0000000000
- E-Mail: menditto@clinicamediterranea.it
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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).
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Placebo.
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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.
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placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Vaginal Health Index (VHI) score.
Zeitfenster: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
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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).
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Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Vaginal pH
Zeitfenster: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days)
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Vaginal pH measured by rapid semiquantitative dry chemical method.
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Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days)
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Subjective symptoms
Zeitfenster: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
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Subjective symptoms (itching, burning, pain) via Visual Analog Scale (VAS 0-10) using daily diary.
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Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
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Quality of life SF-12
Zeitfenster: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
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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)
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Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
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Tollerability
Zeitfenster: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
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All treatment-related adverse reactions (mild, moderate, severe) over the three treatment phases (7+4+3 days) will be recorded.
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Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
9. Juli 2026
Primärer Abschluss (Geschätzt)
30. November 2026
Studienabschluss (Geschätzt)
30. November 2026
Studienanmeldedaten
Zuerst eingereicht
8. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juli 2026
Zuerst gepostet (Tatsächlich)
14. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Infektionen
- Genitalerkrankungen, weiblich
- Bakterielle Infektionen
- Bakterielle Infektionen und Mykosen
- Vaginitis
- Vaginale Erkrankungen
- Vaginose, bakteriell
Andere Studien-ID-Nummern
- ROVUL-25
- 44042-44053-44057-44082 (Andere Kennung: Italian Health Ministry)
Plan für individuelle Teilnehmerdaten (IPD)
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UNENTSCHIEDEN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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