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Tests treatment safety and results for Vulvovaginal Candidiases
Official title Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
ClinicalTrials.gov ID: NCT07109869
What this study is testing
What is Boric acid?
Boric acid is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for vulvovaginal candidiases.
Also referred to as Orthoboric acid, Hydrogen orthoborate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- Patients with known or suspected other active infectious causes of cervicitis, vaginitis, or vulvitis (eg, BV, Chlamydia trachomatis, Neisseria...
- Patients who have undergone any vaginal rejuvenation procedure (ie, laser) within 4 weeks prior to Screening or plan to undergo a vaginal...
- Patients who will undergo evaluation or treatment during the clinical study for abnormal cytology or findings from high-risk HPV testing or Pap test...
- 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;
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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).
What rules you out
- 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...
- 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;
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients currently have or suspect to have an active urinary tract infection (UTI) based on urinalysis and clinical assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Huntington Park, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Sherman Oaks, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Johns Creek, Georgia, United States
- Idaho Falls, Idaho, United States
- Covington, Louisiana, United States
- Marrero, Louisiana, United States
- Dearborn Heights, Michigan, United States
- Fayetteville, North Carolina, United States
- Raleigh, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Lima, Ohio, United States
- Chattanooga, Tennessee, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Huntington Park, California, United States; Los Angeles, California, United States; San Diego, California, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.