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 is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.

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