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The pHlora study is a phase 3 clinical study for females that have been diagnosed with vulvovaginal candidiasis (VVC), commonly known as a vaginal yeast infection.
This study aims to investigate the effectiveness of study drug, boric acid vaginal inserts, in treating vaginal yeast infections.
Study participants may be able to join the study if they meet the following requirements:
Must be a biological female
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Confirmed diagnosis of vulvovaginal candidiasis (VVC), also known as a vaginal yeast infection
Other study requirements will apply.
Participation in the pHlora study will last approximately 1 month.
The study will include screening, study treatment period, several study clinic visits to evaluate your symptoms and overall health, and filling out an e-diary daily. Screening and study treatment may occur on the same day.
If you decide to participate, you can expect to complete the following steps:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Take the pre-screener to see if you may qualify.
See if You May QualifyThe study medication in the pHlora Study is boric acid. Boric acid is a natural chemical component that has antifungal and antimicrobial properties. In this study, boric acid will be administered in the form of a capsule that is inserted into the vagina. This study aims to measure whether boric acid vaginal inserts can safely reduce yeast overgrowth and effectively treat people with vulvovaginal candidiasis (VVC).
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If you qualify for the pHlora study, you may receive boric acid or placebo. Placebo looks like the study medication but has no active ingredients. Researchers use a placebo to help measure the true effectiveness of a treatment.
You will be randomly assigned to receive either the study medication or placebo. You have a 2/3 (about 66%) chance of receiving the study medication. Neither you nor your study team will know your assignment, but someone from the study team can find out in case of an emergency.
Investigational means the study medication is not yet approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like the pHlora study.
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Vulvovaginal candidiasis, also known as a vaginal yeast infection or thrush, is a type of fungal infection. Normally, the vaginal area maintains a healthy balance of bacteria and Candida yeast cells, which live harmlessly in the vagina, on the surrounding skin, and in other areas of the body like the mouth, throat, and gut. However, when the vaginal environment changes—due to factors like antibiotics, hormonal shifts, unbalanced vaginal pH, or a weakened immune system—this balance can be disrupted. When Candida yeast begins to outnumber the healthy bacteria, it can overgrow and cause an infection. While uncomfortable, yeast infections are usually treatable with antifungal medications. The safety and effectiveness of boric acid vaginal inserts is being evaluated as a potential antifungal medication treatment for yeast infections.
Common VVC / yeast infection symptoms include:
To learn more about VVC / vaginal yeast infections, talk to your health care provider or visit:
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you.