Multicenter study for comparison of the efficacy of vaginal capsules with boric acid and probiotics versus other vaginal drugs, in patients with bacterial or fungal vaginal infection.

Multicenter pilot study for comparison of the efficacy of vaginal capsules with boric acid and L. gasseri and L. rhamnosus versus other vaginal drugs, in patients with bacterial or candida Vulvovaginitis.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000371-24-ES

Enrollment

Unknown

Registered

2016-03-18

Start date

2016-05-24

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial or candidiasic vulvovaginitis

Interventions

Trade Name: Iside 22 (Italy) Product Name: Boric acid + L. gasseri y L. rhamnosus Product Code: 0546 Pharmaceutical Form: Vaginal capsule INN or Proposed INN: BORIC ACID CAS Number: 10043-35-3 Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women: >18 years. With symptoms of vulvovaginal infection. IC delivered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Clinical evidence of Chlamydia trachomatis, Trichomona vaginalis, Neisseria gonorrhoeae o Herpes simplex. - Use of antifungal or probiotics during the last 2 weeks before the study. - Patients receiving other treatment with probiotics, vitamin complexes that could interfere significantly with the study evaluations. - Pregnant patients. - Patients capable of becoming pregnant. - Patients menstruating at the time of inclusion. - Breast-feeding. - Immunocompromised patients. - Patients who, based on the judgment of the investigator, is not foreseen will complete the follow.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of use of a vaginal form with boric acid and probiotics for the treatment of symptomatic episodes of vulvovaginitis (VV) against a control treatment drug (regarding a VV etiology);Secondary Objective: To determine the incidence of recurrence / relapse within 3 months.;Primary end point(s): - Number of patients with resolution of symptoms in each group at 2 weeks of the treatment.;Timepoint(s) of evaluation of this end point: 1 months	—

Measure

Time frame

Main Objective: To evaluate the efficacy of use of a vaginal form with boric acid and probiotics for the treatment of symptomatic episodes of vulvovaginitis (VV) against a control treatment drug (regarding a VV etiology);Secondary Objective: To determine the incidence of recurrence / relapse within 3 months.;Primary end point(s): - Number of patients with resolution of symptoms in each group at 2 weeks of the treatment.;Timepoint(s) of evaluation of this end point: 1 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Number of patients with recurrence of VV during the monitoring in each treatment group (incidence of relapse at 3 months). - Changes in vaginal pH level in each group. - Number of patients with "clue cells" or hyphae smear fresh. - Profile and proportion of isolation of pathogens in culture. - Increased population of Lactobacillus spp. post-treatment. - Rescue success rate in the different scenarios. - Relationship between compliance and treatment effectiveness. - Relationship between compliance and recurrence at 3 months. - Percentage of cases with good tolerability of the treatment. - Rate of adverse events. - Tolerability of treatment. - Proportion of patients with mixed infections (VC + VB);Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Secondary end point(s): - Number of patients with recurrence of VV during the monitoring in each treatment group (incidence of relapse at 3 months). - Changes in vaginal pH level in each group. - Number of patients with "clue cells" or hyphae smear fresh. - Profile and proportion of isolation of pathogens in culture. - Increased population of Lactobacillus spp. post-treatment. - Rescue success rate in the different scenarios. - Relationship between compliance and treatment effectiveness. - Relationship between compliance and recurrence at 3 months. - Percentage of cases with good tolerability of the treatment. - Rate of adverse events. - Tolerability of treatment. - Proportion of patients with mixed infections (VC + VB);Timepoint(s) of evaluation of this end point: 3 months

—

Countries

Spain

Contacts

Public ContactJordi Amigó

Clever Instruments

clever@recerca.com0034932080000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026