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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Boric acid
DrugBoric 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.
Placebo
Other interventionPlacebo vaginal inserts containing anhydrous lactose and 1% magnesium stearate are also manufactured and filled into white, opaque hypromellose capsules. Packaged in clear blisters.
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: 14 days 600 mg boric acid insertsExperimental treatment 1 intervention
Group B: 7 days 600 mg boric acid inserts followed by 7 days placebo insertsExperimental treatment 2 interventions
Group C: 14 days placebo insertsPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with the absence of all signs and symptoms of vulvovaginal candidiasis
The proportion of patients who achieve clinical cure (defined as the absence of all signs and symptoms of vulvovaginal candidiasis (VVC) \[ie, composite VSS score = 0\] in the absence of additional antifungal treatment), at the test-of-cure (TOC) visit. This is the proportion of patients in the modified ITT (mITT) Population with clinical cure. * Signs: vulvovaginal edema, erythema, excoriation/fissures; * Symptoms: vulvovaginal itching, burning, irritation; and * Severity of each sign and symptom graded on a 0 to 3 rating scale: * Absent = 0; * Mild = 1; * Moderate = 2; or * Severe = 3.
Time frame
28 days (+ 2 days)Secondary outcomes
1
Proportion of patients with clinical cure at the end-of-treatment visit
Proportion of patients with clinical cure at the end-of-treatment visit in the modified intent to treat (mITT) and clinically evaluable (CE) populations.
Time frame
15 days (+ 2 days)2
Proportion of patients with clinical cure at the test-of-cure visit
Proportion of patients with clinical cure at the test-of-cure (TOC) visit in the per protocol and clinically evaluable (CE) populations.
Time frame
28 days (+ 2 days)3
Proportion of patients with mycological eradication at the end-of-treatment visit
Proportion of patients with mycological eradication at the end-of-treatment (EOT) visit in the modified intent to treat (mITT) population.
Time frame
14 days (+ 2 days)4
Proportion of patients with mycological eradication at the test-of-cure visit
Proportion of patients with mycological eradication at the test-of-cure (TOC) visit in the modified intent to treat (mITT) and clinically evaluable (CE) populations.
Time frame
28 days (+ 2 days)Sponsors and contacts
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Source ClinicalTrials.gov