AzTrials
AzTrials

Vulvovaginal CandidiasesPhase 3NCT07109869

Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis

A Phase 3 study testing Boric acid in people with Vulvovaginal Candidiases and Vulvovaginal Candidiasis, Genital, run by pH-D Feminine Health LLC at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older, women only
What is being tested?
Boric acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
333 participants
Where
26 sitesUnited States
Study dates
8 Aug 2025to 12 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 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.
  • 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;
Show all 23Show fewer
  • 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 qualified 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 qualified 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).

Who cannot join

  • 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;
  • Patients diagnosed with BV, determined by meeting 3 of the 4 Amsel's criteria:
  • A fishy odor of the vaginal discharge before or after the addition of a drop of 10% KOH (ie, a positive whiff test);
  • Homogenous, thin discharge (milk-like consistency) that smoothly coats the vaginal walls;
Show all 31Show fewer
  • At least 20% of epithelial cells are clue cells (eg, vaginal epithelial cells studded with adherent bacteria) on saline wet mount microscopic evaluation of vaginal discharge; or
  • pH of vaginal fluid >4.5.
  • Patients currently undergoing treatment for or with a history of treatment for cervical, vaginal, or vulvar cancer;
  • Patients using any systemic (eg, oral or injectable) corticosteroid treatment during the study or within 30 days prior to Screening;
  • Patients using topical steroids applied to the vulvar or vaginal regions during the study or within 7 days prior to Screening;
  • Patients using any systemic (eg, oral or injectable) or topical (applied to the vulvar or vaginal regions) antimicrobials including antifungal, antiviral, antibacterial, or anti-trichomonal drugs during the clinical study or within 14 days prior to Screening;
  • Patients using any prescription (eg, vaginal estrogen, ospemifene, prasterone) or non-prescription intravaginal or vulvar product (eg, vitamin E gel capsules [vaginal inserts], lubricants, moisturizers, douches, creams, or spermicides) within 7 days prior to Screening and through Day 28 (Visit 5);
  • Patients unwilling to refrain from the use of intravaginal products (eg, douches, creams, spermicides, yoni eggs, tampons, menstrual cups, and any other such intravaginal product that, in the opinion of the PI, would be considered exclusionary) during the Treatment Period, inclusive of Day 14;
  • Patients with a current immunocompromising condition (ie, HIV, end-stage renal disease);
  • Patients using any immunosuppressive medication (included, but not limited to, carbamazepine, cyclosporine, tacrolimus, methotrexate, 6 mercaptopurine, or mycophenolate) or radiation treatment within 3 months prior to Screening or during the clinical study;
  • Patients with a history of pelvic radiation treatment;
  • Patients with a clinically significant major organ disease, cancer, infection (except acute VVC), or other condition that may affect the clinical assessment of VVC or render the patient a poor study candidate, per the PI's judgment;
  • Patients with any comorbid condition that would preclude the safe participation of the patient in the clinical study or would prevent the patient from meeting the clinical study requirements, per the PI's judgment;
  • Patients with diabetes mellitus type I, use of insulin (current or anticipated need during the study), or poorly-controlled diabetes mellitus type II, defined as (hemoglobin A1c [(HbA1c]) of 10% or higher result within the prior 6 months) or at Screening;
  • Patients with any laboratory abnormality that, in the opinion of the PI, would likely introduce additional risk to the patient or might interfere with data interpretation. The findings noted below are particularly exclusionary:
  • Serum alanine aminotransferase ≥2.5 × the upper limit of normal (ULN) of the reference range;
  • Serum aspartate aminotransferase ≥2.5 × the ULN of the reference range; or
  • Serum total bilirubin ≥2 × the ULN of the reference range, unless the elevation is consistent with Gilbert's syndrome
  • Patients with a known history of HIV, hepatitis B, or hepatitis C virus (HCV), or a positive test for HIV antibody, hepatitis B surface antigen, or HCV antibody;
  • Patients who are pregnant (ie, a positive pregnancy test at Screening), lactating, or planning to become pregnant during the clinical study period;
  • Patients with a planned surgery or other medical procedure that would impact compliance with the Protocol, per the PI's discretion;
  • Patients with a current or recent history (eg, the past 12 months) of substance abuse (including alcohol) or any other medical, psychiatric, or other condition that, in the PI's opinion, would preclude compliance with the Protocol;
  • Patients currently participating or had participated in another clinical study within the 30 days prior to Screening;
  • Patients currently have or expect, within the Treatment Period, to have heavy menstrual bleeding (defined as "flooding" or bleeding through ≥1 tampon or sanitary pad in 2 hours or less with most periods) or a menstrual duration >7 days; or
  • Patients currently have or suspect to have an active urinary tract infection (UTI) based on urinalysis and clinical assessment.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Chattanooga Medical Research, Chattanooga

    Chattanooga, Tennessee, 37412

  • Complete Health Care for Women

    Columbus, Ohio, 43231

  • Clinical Trials Management, LLC - Northshore

    Covington, Louisiana, 70433

  • Revive Research Institute, Inc.

    Dearborn Heights, Michigan, 48126

  • Cross Creek Medical Clinic, PA

    Fayetteville, North Carolina, 28304

  • TMC Life Research, Inc

    Houston, Texas, 77054

  • Century Research Institute, Inc

    Huntington Park, California, 90255

  • Leavitt Clinical Research

    Idaho Falls, Idaho, 83404

  • Jackson Clinic

    Jackson, Tennessee, 38305

  • One Health Research Clinic Inc.

    Johns Creek, Georgia, 30097

  • Nexgen Research

    Lima, Ohio, 45801

  • Applied Research Center of Arkansas Inc.

    Little Rock, Arkansas, 72205

  • Matrix Clinical Research

    Los Angeles, California, 90057

  • Praetorian Pharmaceutical Research

    Marrero, Louisiana, 70072

  • SMS Clinical Research, LLC

    Mesquite, Texas, 75149

  • Project 4 Research Inc

    Miami, Florida, 33125

  • Entrust Clinical Research

    Miami, Florida, 33176

  • Felicidad Medical Research, LLC

    Miami, Florida, 33184

  • Alliance for Multispecialty Research - Mobile

    Mobile, Alabama, 36608

  • Unified Women's Clinical Research - Raleigh

    Raleigh, North Carolina, 27607

  • National Clinical Trials - VA

    Reston, Virginia, 20190

  • M3 Wake Research - San Diego

    San Diego, California, 92111

  • Integrated Clinical Research LLC

    Sherman Oaks, California, 91403

  • Better Life Clinical Research, LLC

    Tampa, Florida, 33607

  • Helping Hands Health Center

    Tampa, Florida, 33634

  • Unified Women's Clinical Research - Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the detailed 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, activity following study drug administration, and whether the bladder was emptied prior to administration);
  • Vulvovaginal symptoms;
  • Any adverse symptoms or symptoms of concern, illnesses, or physical injuries that occur while participating in the clinical study;
  • Contraceptive methods utilized;
  • Days of menstrual bleeding, including days of heavy menstrual bleeding (defined as "flooding" or bleeding through ≥1 tampon or sanitary pad in 2 hours or less), start date of menstrual cycle, end date of menstrual cycle, and daily quantity of menstrual hygiene product(s) utilized for each day of menses;
  • Position (eg, laying down supine, prone, on side) following study drug administration;
  • Vulvovaginal sexual activity, including if the sexual activity occurred before or after study drug administration; and
  • The presence of any non-exclusionary intravaginal foreign objects (ie, contraceptive vaginal ring, diaphragm, cervical cap, condom, sex toys).

Patients will complete a total of 4 in-person visits at Screening, on Day 7 (Visit 2) (±2 days), Day 15 (Visit 3) (+2 days), and Day 28 (Visit 5) (±2 days), as well as a telephone Follow-Up Visit on Day 21 (Visit 4) (±2 days) (if clinically indicated, the Follow-Up Visit may be performed in-person).

Clinical, mycological, and overall outcomes will be assessed at Day 15 (Visit 3) and Day 28 (Visit 5) for all study arms. If persistent symptoms are present at any visit, a full microbiologic evaluation to assess for persistence of VVC (including KOH wet mount, saline wet mount, and vaginal fungal culture) will be performed. Additionally, screening tests required to rule out other potential causes of symptoms may be performed or repeated at PI or qualified designee discretion. Patients may also be provided with a rescue treatment at PI or qualified designee discretion.

Individual patient participation is expected to be 28 days.

Being tested
Boric acid, Placebo
Keywords
Vulvovaginal Candidiases, VVC
Medical subject headings
Candidiasis, Vulvovaginal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boric acidDrug

    Also called Orthoboric acid, Hydrogen orthoborate, Trihydroxidoboron

    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.

  • PlaceboOther

    Placebo vaginal inserts containing anhydrous lactose and 1% magnesium stearate are also manufactured and filled into white, opaque hypromellose capsules. Packaged in clear blisters.

Study groups in NCT07109869
Study groupRoleWhat they receive
14 days 600 mg boric acid insertsExperimentalAll patients will self-administer 600 mg boric acid vaginal inserts once daily for 14 days.
Receives: Drug: Boric acid
7 days 600 mg boric acid inserts followed by 7 days placebo insertsExperimentalAll patients will self-administer 600 mg boric acid vaginal inserts once daily for first 7 days and placebo vaginal inserts for following 7 days.
Receives: Drug: Boric acid; Other: Placebo
14 days placebo insertsPlacebo comparatorAll patients will self-administer placebo vaginal inserts once daily for 14 days.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28 days (+ 2 days)

Secondary outcomes (11)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 28 days (+ 2 days)

  5. Proportion of patients with overall cure at the end-of-treatment visit

    Proportion of patients with both clinical cure and mycological eradication (ie, overall cure) at the end-of-treatment (EOT) visit in the modified intent to treat (mITT) and clinically evaluable (CE) populations.

    Measured: 15 days (+ 2 days)

  6. Proportion of patients with overall cure at the test-of-cure visit

    Proportion of patients with both clinical cure and mycological eradication (ie, overall cure) at the test-of-cure (TOC) visit in the modified intent to treat (mITT) and clinically evaluable (CE) populations.

    Measured: 28 days (+ 2 days)

  7. Proportion of patients with clinical cure at both the end-of-treatment and test-of-cure visits

    Proportion of patients with clinical cure at both the end-of-treatment (EOT) and test-of-cure (TOC) visits in the modified intent to treat (mITT) and clinically evaluable (CE) populations.

    Measured: 28 days (+ 2 days)

  8. Proportion of patients with composite vulvovaginal signs and symptoms score >0 but <4 in the absence of additional antifungal treatment at the end-of-treatment visit

    Proportion of patients with composite vulvovaginal signs and symptoms (VSS) score >0 but <4 in the absence of additional antifungal treatment at the end-of-treatment (EOT) visit in the modified intent to treat (mITT) population.

    The VSS scale is a standardized, predefined scale for which each sign and symptom is given a numerical rating based on severity (absent = 0; mild = 1; moderate = 2; and severe = 3) to calculate a total composite VSS score (range of 0 to 18). Signs include edema, erythema, and excoriation/fissures. Symptoms include vulvovaginal burning, itching, and irritation.

    Measured: 15 days (+ 2 days)

  9. Proportion of patients with composite vulvovaginal signs and symptoms score >0 but <4 in the absence of additional antifungal treatment at the test-of-cure visit

    Proportion of patients with composite vulvovaginal signs and symptoms (VSS) score >0 but <4 in the absence of additional antifungal treatment at the test-of-cure (TOC) visit in the modified intent to treat (mITT) and clinically evaluable (CE) populations.

    The VSS scale is a standardized, predefined scale for which each sign and symptom is given a numerical rating based on severity (absent = 0; mild = 1; moderate = 2; and severe = 3) to calculate a total composite VSS score (range of 0 to 18). Signs include edema, erythema, and excoriation/fissures. Symptoms include vulvovaginal burning, itching, and irritation.

    Measured: 28 days (+ 2 days)

  10. Proportion of patients with individual signs and symptoms scores that remain >0, but have improved from baseline in the absence of additional antifungal treatment

    Proportion of patients with individual signs and symptoms scores that remain >0, but have improved from baseline in the absence of additional antifungal treatment, meeting the following criteria in the modified intent to treat (mITT) and clinically evaluable (CE) populations:

    • Baseline mild (severity = 1) rating resulting in an absence rating at the end-of-treatment (EOT) and test-of-cure (TOC) visits;
    • Baseline moderate (severity = 2) rating resulting in a mild (severity = 1) or absence (severity = 0) rating at the EOT and TOC visits; or
    • Baseline severe (severity = 3) rating resulting in a moderate (severity = 2), mild (severity = 1), or absence (severity = 0) rating at the EOT and TOC visits.

    Measured: 28 days (+ 2 days)

  11. Proportion of patients with complicated vulvovaginal candidiasis

    Proportion of patients with complicated vulvovaginal candidiasis (VVC) not meeting any study exclusion criteria (that is, VVC with the isolation of non-albicans Candida species [eg, Candida glabrata], severe symptoms [ie, vulvovaginal signs and symptoms (VSS) score ≥7 at screening], and/or recurrent episodes [defined as 3 or more episodes of symptomatic infection within 1 year, inclusive of the study-qualifying infection]) with clinical cure, mycological cure, and overall cure at the end-of-treatment (EOT) and test-of-cure (TOC) visits in the modified intent to treat (mITT) and clinically evaluable (CE) populations.

    The VSS scale is a standardized, predefined scale for which each sign and symptom is given a numerical rating based on severity (absent = 0; mild = 1; moderate = 2; and severe = 3) to calculate a total composite VSS score (range of 0 to 18). Signs include edema, erythema, and excoriation/fissures. Symptoms include vulvovaginal burning, itching, and irritation.

    Measured: 28 days (+ 2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start8 Aug 2025
  3. Primary completion12 Aug 2026
  4. Study completion12 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109869
Sponsor's protocol ID
PHD-CLIN-BOR302
Status last verified
Oct 2026
First submitted
31 Jul 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Boric acid in people with Vulvovaginal Candidiases and Vulvovaginal Candidiasis, Genital, run by pH-D Feminine Health LLC at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with the absence of all signs and symptoms of vulvovaginal candidiasis (time frame: 28 days (+ 2 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07109869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in