NCT07109869 · pH-D Feminine Health LLC
Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
What this study is about
This is a Phase 3 clinical study to evaluate the effectiveness, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.
View original scientific description
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.
Interventions
DRUG
Boric 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.
OTHER
Placebo
Placebo vaginal inserts containing anhydrous lactose and 1% magnesium stearate are also manufactured and filled into white, opaque hypromellose capsules. Packaged in clear blisters.
Primary outcome measures
Proportion of patients with the absence of all signs and symptoms of vulvovaginal candidiasis
Time frame: 28 days (+ 2 days)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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. 3. 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 rep
Where
- Mobile, Alabama
- Phoenix, Arizona
- Little Rock, Arkansas
- Huntington Park, California
- Los Angeles, California
- San Diego, California
- Sherman Oaks, California
- Miami, Florida
- Tampa, Florida
- Johns Creek, Georgia
- Idaho Falls, Idaho
- Covington, Louisiana
And 12 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations