Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age12+
SponsorpH-D Feminine Health LLC
About this trial
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.
Eligibility criteria
Qualifiers
Patients who are postmenarcheal, nonpregnant biological females, 12 years of age and older, at Screening;
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) and symptoms (vulvovaginal burning, itching, and irritation) as rated using the VSS Scale.
Disqualifiers
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);
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;
A fishy odor of the vaginal discharge before or after the addition of a drop of 10% KOH (ie, a positive whiff test);
Trial design
Treatments tested in this trial
- Boric acid
- Placebo
Treatment groups
400 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov