Boric Acid Inserts for Vaginal Yeast Infection

Recruiting at 19 trial locations

Overseen By Clinical Trial Manager

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: pH-D Feminine Health LLC

Must not be taking: Steroids, Antimicrobials, Immunosuppressants, others

Disqualifiers: Infections, Cancer, Diabetes, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 14 days

201 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether boric acid vaginal inserts can safely and effectively treat vaginal yeast infections. Participants will use either boric acid inserts or a placebo (an inactive substance) for 14 days to determine which is more effective. The trial seeks women experiencing symptoms such as burning, itching, and irritation from a current yeast infection. Participants should be comfortable using inserts and agree to avoid tampons and oral intercourse during the treatment period. As a Phase 3 trial, this study is the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as systemic or topical corticosteroids, antimicrobials, and intravaginal products, before and during the study. If you are on these medications, you may need to stop them for a specific period before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that boric acid vaginal inserts are generally safe when used correctly. Studies have found that a 600 mg boric acid insert, used daily for 14 days, is both safe and effective for treating vaginal yeast infections. Most people tolerate it well. Mild skin irritation is the most common side effect, which is usually not serious and can be managed by adjusting the dose. This method has been a popular and trusted treatment for these infections. Following the instructions is important to minimize any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard antifungal treatments like fluconazole or clotrimazole, which are commonly used for vaginal yeast infections, boric acid inserts offer a unique approach. Researchers are excited about these treatments because boric acid is thought to restore the natural pH balance of the vagina, creating an environment less conducive to yeast growth. Additionally, the delivery method via inserts allows for targeted, localized treatment, which may lead to quicker symptom relief. With variations in the treatment duration and combination with placebo, these inserts could provide flexible options for managing yeast infections more effectively.

What evidence suggests that boric acid inserts could be an effective treatment for vaginal yeast infection?

Research has shown that boric acid effectively treats vaginal yeast infections by reducing symptoms and inhibiting yeast growth. Studies have reported cure rates ranging from 40% to 100%, depending on treatment specifics and patient groups. One study found an average cure rate of 76% for boric acid in treating vulvovaginal candidiasis, a type of yeast infection. In this trial, participants will receive either 14 days of 600 mg boric acid inserts, 7 days of 600 mg boric acid inserts followed by 7 days of placebo inserts, or 14 days of placebo inserts. Patients have reported high satisfaction with boric acid treatment and few side effects. Overall, boric acid appears to be a promising option for those dealing with yeast infections. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trial Manager

Principal Investigator

Medpace GmbH

Are You a Good Fit for This Trial?

This trial is for nonpregnant females aged 12 and older with a vaginal yeast infection, who can insert the treatment and undergo pelvic exams. They must use contraception if of childbearing potential, abstain from oral intercourse during treatment, avoid tampons/menstrual cups, and have no heavy menstrual bleeding or active urinary infections.

Inclusion Criteria

I currently have symptoms of a yeast infection.

Patients must be willing to abstain from receiving oral intercourse during the Treatment Period

My cervical cancer screening results meet the required criteria.

Exclusion Criteria

Patients with specific laboratory abnormalities

Patients with current or recent history of substance abuse or conditions affecting Protocol compliance

I experience heavy or prolonged menstrual periods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants self-administer boric acid or placebo vaginal inserts once daily for 14 days

14 days

3 visits (in-person), 1 visit (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Boric Acid Inserts

Trial Overview The study tests the safety and effectiveness of boric acid 600 mg vaginal inserts compared to a placebo in treating vulvovaginal candidiasis (VVC). It's a Phase 3 trial where participants are randomly assigned to receive either the boric acid inserts or placebo.

How Is the Trial Designed?

Group I: 7 days 600 mg boric acid inserts followed by 7 days placebo inserts Experimental Treatment 2 Interventions

All patients will self-administer 600 mg boric acid vaginal inserts once daily for first 7 days and placebo vaginal inserts for following 7 days.

Group II: 14 days 600 mg boric acid inserts Experimental Treatment 1 Intervention

All patients will self-administer 600 mg boric acid vaginal inserts once daily for 14 days.

Group III: 14 days placebo inserts Placebo Group 1 Intervention

All patients will self-administer placebo vaginal inserts once daily for 14 days.

Who Is Running the Clinical Trial?

pH-D Feminine Health LLC

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6878170/

Clinicians' use of Intravaginal Boric Acid Maintenance ... Average length of use was 13 months with high patient satisfaction and few adverse events. Prospective studies are needed to evaluate the ...

2. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2022.950215/full

Effects of Boric Acid Gel on Vaginal Candida albicans ... The boric acid significantly reduced the symptoms associated with CA vaginal infection. It inhibited the CA growth, prevented vaginal lesions, promoted the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163445307006615

Prolonged (3-month) mycological cure rate after boric acid ... With 74% mycological cure at 15th day, this would indicate that on an average only 46.6% of diabetic women with VVC would remain cured at 3 months after a ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21774671/

Boric acid for recurrent vulvovaginal candidiasis The mycologic cure rates varied from 40% to 100% in patients treated with boric acid; 4 of the 9 included case series reported statistically significant ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/2024/2807070

Boric Acid for the Treatment of Vaginitis: New Possibilities ... An average cure rate of 76% was found for vulvovaginal candidiasis BA treatment. Recurrent bacterial vaginosis was controlled with BA and 5- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10100571/

Data on safety of intravaginal boric acid use in pregnant ... BA vaginal suppositories 600mg daily for 14 days are a “safe and effective alternative (Grade 1B).” If mucosal irritation occurs dose can be ...

7. my.clevelandclinic.org my.clevelandclinic.org/health/drugs/19641-boric-acid-vaginal-suppository

Boric Acid Suppositories: Uses & Side Effects Boric acid suppositories help promote a balance of acid in your vagina. They can also treat vaginal yeast infections by relieving symptoms.

8. columbiadoctors.org columbiadoctors.org/health-library/article/boric-acid-vaginal-yeast-infection/

Boric Acid for Vaginal Yeast Infection Information How safe is it? When used in capsules as a vaginal suppository, boric acid is only known to sometimes cause skin irritation. But when used by mouth ...

9. drugs.com drugs.com/mtm/boric-acid-vaginal.html

Boric acid vaginal Uses, Side Effects & Warnings The usual dosage of vaginal boric acid for a chronic vaginal yeast infection is 1 suppository inserted into the vagina once per day, for 6 days in a row. Wash ...

10. evvy.com evvy.com/blog/boric-acid-suppositories-side-effects

Boric Acid Suppositories: Side Effects to Be Aware Of Boric acid suppositories are generally safe and well-tolerated when used vaginally and exactly as directed. They're a popular option to treat ...