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

NCT07703241 | Not Yet Recruiting

• 2 other identifiers: ROVUL-2544042-44053-44057-44082
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Vaginosis; Candidal Vaginitis

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  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

  Baseline (T0), end of first treatment cycle (T-7 days), end of first month (T-28 days), end of follow-up (T-112 days).

Study Arms (2)

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).

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.

Other: Placebo.

Interventions

Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms. DEVICE

Placebo.

INTIMIQUE OVULI

Placebo. OTHER

placebo ovules (inert lipid base, free of active functional substances - no lactic acid, tyndallized probiotics, or sodium hyaluronate)

PLACEBO

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• ROELMI HPC: lead

Study Sites (1)

Clinica Mediterranea

Naples, 80122, Italy

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Chiara Trombetta

CONTACT

00000000000000; chiara.trombetta@roelmihpc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo ovules are identical in appearance, consistency, color, packaging, and administration method to the active device; neither participants nor the principal investigator knows group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two parallel arms (1:1 randomization).

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

IT (1)