Bacterial VaginosisROVUL-25NCT07703241
Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).
A study testing Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms. in people with Bacterial Vaginosis and Candidal Vaginitis, run by ROELMI HPC at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Bacterial Vaginosis, Candidal Vaginitis
- What is being tested?
- Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jul 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Clinica Mediterranea
Naples, 80122
Agostino Menditto, Dr., 0000000000, menditto@clinicamediterranea.it
About this study
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.
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.
Read the 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).
- Conditions
- Bacterial Vaginosis, Candidal Vaginitis
- Being tested
- Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms., Placebo.
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.Device
Placebo.
Placebo.Other
placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate)
| Study group | Role | What they receive |
|---|---|---|
| INTIMIQUE OVULI | Experimental | 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). Receives: Device: Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms. |
| PLACEBO | Placebo comparator | 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. Receives: Other: Placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (4)
Vaginal pH
Vaginal pH measured by rapid semiquantitative dry chemical method.
Measured: 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
Subjective symptoms (itching, burning, pain) via Visual Analog Scale (VAS 0-10) using daily diary.
Measured: 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
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)
Measured: 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
All treatment-related adverse reactions (mild, moderate, severe) over the three treatment phases (7+4+3 days) will be recorded.
Measured: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start9 Jul 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms (1:1 randomization).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ROELMI HPC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703241
- Sponsor's protocol ID
- ROVUL-25
- Other IDs
- 44042-44053-44057-44082
- Acronym
- ROVUL-25
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07703241
- Acronym / sponsor ID
- ROVUL-25 / ROVUL-25
- Conditions
- Bacterial Vaginosis, Candidal Vaginitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ROELMI HPCIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms (1:1 randomization).
| Arm | Type | Receives |
|---|---|---|
| INTIMIQUE OVULI | Experimental | Device: Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.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). |
| PLACEBO | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- Male sex
- Age < 18 or > 60 years
- Pregnant, suspected pregnant, or planning pregnancy during the study period
- Breastfeeding
- Not self-sufficient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.Placebo. | Device | INTIMIQUE OVULI |
| Placebo.placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate) | Other | PLACEBO |
Primary outcome
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).
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).
4 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms. in people with Bacterial Vaginosis and Candidal Vaginitis, run by ROELMI HPC at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Trombetta (00000000000000, chiara.trombetta@roelmihpc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.