Safety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis (VVC)
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.
• 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:
‣ A potassium hydroxide (KOH) wet mount or saline preparation performed from the inflamed vaginal mucosa or secretions demonstrating yeast forms (hyphae or pseudohyphae) of budding yeast;
⁃ Vaginal pH ≤4.5; and
⁃ Total Vulvar Signs and Symptoms (VSS) Scale score of ≥4: vulvovaginal signs (edema, erythema, and excoriation/fissures) and symptoms (vulvovaginal burning, itching, and irritation) as rated using the VSS Scale.
• 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 between 21 and 29 years of age must have a cervical cancer screening test (Papanicolaou \[Pap\] smear) performed at Screening or have a documented Pap smear result within 1 year of Screening which must be available for the assessment by the PI or designee at the Screening Visit; and
⁃ Patients 30 years of age and older must have documented cervical cancer screening tests (Pap smear and high-risk human papillomavirus \[HPV\]) performed at Screening or have documented results within 1 year of Screening which must be available for the assessment by the PI or designee at the Screening Visit.
• 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):
‣ Copper intrauterine device used continuously and successfully for at least 90 days prior to the first dose of study drug;
⁃ Levonorgestrel-releasing intrauterine system used successfully for at least 90 days prior to the first dose of study drug;
⁃ Progestin implant used successfully for at least 90 days prior to the first dose of study drug;
⁃ Monogamy with a vasectomized male partner (medical assessment of the surgical success of the vasectomy must have occurred at least 6 months prior to the first dose of study drug);
⁃ Abstinence; or
⁃ Use of 1 of the following hormonal methods in combination with 1 of the following barrier methods:
• Hormonal methods
∙ Barrier methods
• Patients must be willing to avoid tampon or menstrual cup use during the Treatment Period (ie, Day 1 to Day 14); and
⁃ Patients must be willing to abstain from receiving oral intercourse during the Treatment Period (ie, Day 1 to Day 14).