Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis (NCT07109869) | Clinical Trial Compass
RecruitingPhase 3
Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
United States400 participantsStarted 2025-08-08
Plain-language summary
This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.
Who can participate
Age range12 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients who are postmenarcheal, nonpregnant biological females, 12 years of age and older, at Screening;
✓. Patients with acute symptomatic VVC infection at Screening, defined as meeting all of the following criteria:
✓. Patients aged 21 and older must have cervical cancer screening results meeting the following criteria for inclusion at Screening or within the 1 year prior to Screening: negative for intraepithelial lesion or malignancy or clinically insignificant findings not requiring any further surveillance or treatment beyond a repeat cervical cytology test;
✓. Patients must be suitable candidates for vaginal treatment, able to insert the study drug, and are comfortable undergoing pelvic exams;
✓. Patients willing and able to provide written informed consent or assent (for those 12 to 17 years of age);
✓. Patients willing and able to comply with Protocol requirements, instructions, and Protocol-stated restrictions, as determined by the PI;
✓. Patients willing and able to give authorization for use of protected health information;
✓. Patients of childbearing potential (as defined in Inclusion Criterion 1) must use 1 of the following contraceptive options described below through Day 28 (Visit 5):
Exclusion criteria
✕. Patients with known or suspected other active infectious causes of cervicitis, vaginitis, or vulvitis (eg, BV, Chlamydia trachomatis, Neisseria gonorrhoeae, T. vaginalis, or genital lesions consistent with HPV, herpes simplex, syphilis, chancroid, etc) based on the results of clinical assessments, in-clinic microscopic assessments (eg, clue cells or trichomonads detected on saline wet mount), and/or rapid diagnostic tests (RDTs) performed prior to enrollment (eg, OSOM® test, etc);
What they're measuring
1
Proportion of patients with the absence of all signs and symptoms of vulvovaginal candidiasis
✕. Patients who have undergone any vaginal rejuvenation procedure (ie, laser) within 4 weeks prior to Screening or plan to undergo a vaginal rejuvenation procedure prior to completion of the last planned assessment;
✕. Patients who will undergo evaluation or treatment during the clinical study for abnormal cytology or findings from high-risk HPV testing or Pap test finding;
✕. Patients diagnosed with BV, determined by meeting 3 of the 4 Amsel's criteria:
✕. Patients currently undergoing treatment for or with a history of treatment for cervical, vaginal, or vulvar cancer;
✕. Patients using any systemic (eg, oral or injectable) corticosteroid treatment during the study or within 30 days prior to Screening;
✕. Patients using topical steroids applied to the vulvar or vaginal regions during the study or within 7 days prior to Screening;
✕. Patients using any systemic (eg, oral or injectable) or topical (applied to the vulvar or vaginal regions) antimicrobials including antifungal, antiviral, antibacterial, or anti-trichomonal drugs during the clinical study or within 14 days prior to Screening;