Safety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis (VVC)
pH-D Feminine Health LLC
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.
Description
This clinical study will be a multi-center, randomized, placebo-controlled, double-blinded study with a 3-arm design comparing 600 mg boric acid vaginal inserts dosed for 7 or 14 days to placebo. All patients will self-administer vaginal inserts once daily for 14 days. During self-administration of the study drug, patients will be instructed to utilize an electronic diary (eDiary) to record their daily symptoms from Screening through Day 28 (Visit 5). The following information will be recorded in the eDiary: * Study drug administration (including time at which study drug was administered, ac…
Eligibility
- Age range
- 12+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria 1. Patients who are postmenarcheal, nonpregnant biological females, 12 years of age and older, at Screening; 2. Patients with acute symptomatic VVC infection at Screening, defined as meeting all of the following criteria: * A potassium hydroxide (KOH) wet mount or saline wet mount preparation performed from the inflamed vaginal mucosa or secretions demonstrating yeast forms (hyphae or pseudohyphae) of or budding yeast; * Vaginal pH ≤4.5; and * Total Vulvar Signs and Symptoms (VSS) Scale score of ≥4: vulvovaginal signs (edema, erythema, and excoriation/fissures) an…
Interventions
- DrugBoric acid
Boric acid vaginal inserts consisting of 600 mg boric acid drug substance filled into white, opaque hypromellose capsules with no additional excipients included in the formulation. Each vaginal insert is sealed into a clear blister cavity.
- OtherPlacebo
Placebo vaginal inserts containing anhydrous lactose and 1% magnesium stearate are also manufactured and filled into white, opaque hypromellose capsules. Packaged in clear blisters.
Locations (27)
- Alliance for Multispecialty Research - MobileMobile, Alabama
- Abby's Research InstitutePhoenix, Arizona
- Applied Research Center of Arkansas Inc.Little Rock, Arkansas
- Century Research Institute, IncHuntington Park, California
- Matrix Clinical ResearchLos Angeles, California
- M3 Wake Research - San DiegoSan Diego, California