Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vagini… (NCT07703241) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).
Italy80 participantsStarted 2026-07-09
Plain-language 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). 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.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 excess…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Vaginal Health Index (VHI) score.
Timeframe: Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).