RECRUITING

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

Conditions

Vulvovaginal Candidiases Vulvovaginal Candidiasis, Genital Vulvovaginal Candidiasis (VVC)VVC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis (VVC)

Quick Facts

Study Start:2025-08

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07109869

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. 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, KOH/saline wet mount), and/or rapid diagnostic tests (RDTs) performed prior to enrollment (eg, OSOM® test, etc); 2. 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; 3. 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; 4. 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; * Clue cells (eg, vaginal epithelial cells studded with adherent bacteria) on microscopic evaluation of vaginal discharge; or * pH of vaginal fluid \>4.5. 5. Patients currently undergoing treatment for or with a history of treatment for cervical, vaginal, or vulvar cancer; 6. Patients using any systemic (eg, oral or injectable) corticosteroid treatment during the study or within 30 days prior to Screening; 7. Patients using topical steroids applied to the vulvar or vaginal regions during the study or within 7 days prior to Screening; 8. 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; 9. 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); 10. 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; 11. Patients with a current immunocompromising condition (ie, HIV, end-stage renal disease); 12. 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; 13. Patients with a history of pelvic radiation treatment; 14. 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; 15. 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; 16. Patients with diabetes mellitus type I, use of insulin, or poorly-controlled diabetes mellitus type II (hemoglobin A1c \[HbA1c\] of 10 or higher within the prior 6 months) at Screening; 17. 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 18. 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; 19. Patients who are pregnant (ie, a positive pregnancy test at Screening), lactating, or planning to become pregnant during the clinical study period; 20. Patients with a planned surgery or other medical procedure that would impact compliance with the Protocol, per the PI's discretion; 21. 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; 22. Patients currently participating or had participated in another clinical study within the 30 days prior to Screening; 23. 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 24. Patients currently have or suspect to have an active urinary tract infection (UTI) based on urinalysis and clinical assessment.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. 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, KOH/saline wet mount), and/or rapid diagnostic tests (RDTs) performed prior to enrollment (eg, OSOM® test, etc);
2. 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;
3. 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;
4. 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;
* Clue cells (eg, vaginal epithelial cells studded with adherent bacteria) on microscopic evaluation of vaginal discharge; or
* pH of vaginal fluid \>4.5.
5. Patients currently undergoing treatment for or with a history of treatment for cervical, vaginal, or vulvar cancer;
6. Patients using any systemic (eg, oral or injectable) corticosteroid treatment during the study or within 30 days prior to Screening;
7. Patients using topical steroids applied to the vulvar or vaginal regions during the study or within 7 days prior to Screening;
8. 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;
9. 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);
10. 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;
11. Patients with a current immunocompromising condition (ie, HIV, end-stage renal disease);
12. 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;
13. Patients with a history of pelvic radiation treatment;
14. 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;
15. 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;
16. Patients with diabetes mellitus type I, use of insulin, or poorly-controlled diabetes mellitus type II (hemoglobin A1c \[HbA1c\] of 10 or higher within the prior 6 months) at Screening;
17. 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
18. 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;
19. Patients who are pregnant (ie, a positive pregnancy test at Screening), lactating, or planning to become pregnant during the clinical study period;
20. Patients with a planned surgery or other medical procedure that would impact compliance with the Protocol, per the PI's discretion;
21. 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;
22. Patients currently participating or had participated in another clinical study within the 30 days prior to Screening;
23. 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
24. Patients currently have or suspect to have an active urinary tract infection (UTI) based on urinalysis and clinical assessment.

Contacts and Locations

Study Contact

Clinical Trial Manager

CONTACT

513-709-4442

s.sammons@medpace.com

Principal Investigator

Clinical Trial Manager

STUDY_CHAIR

Medpace GmbH

Study Locations (Sites)

Alliance for Multispecialty Research - Mobile

Mobile, Alabama, 36608

United States

Abby's Research Institute

Phoenix, Arizona, 85031

United States

Century Research Institute, Inc

Huntington Park, California, 90255

United States

Matrix Clinical Research

Los Angeles, California, 90057

United States

Project 4 Research Inc

Miami, Florida, 33125

United States

Entrust Clinical Research

Miami, Florida, 33176

United States

Felicidad Medical Research, LLC

Miami, Florida, 33184

United States

Better Life Clinical Research, LLC

Tampa, Florida, 33607

United States

Helping Hands Health Center

Tampa, Florida, 33634

United States

Leavitt Clinical Research

Idaho Falls, Idaho, 83404

United States

Clinical Trials Management, LLC - Northshore

Covington, Louisiana, 70433

United States

Praetorian Pharmaceutical Research

Marrero, Louisiana, 70072

United States

Revive Research Institute, Inc.

Dearborn Heights, Michigan, 48126

United States

Cross Creek Medical Clinic, PA

Fayetteville, North Carolina, 28304

United States

Unified Women's Clinical Research - Raleigh

Raleigh, North Carolina, 27607

United States

Unified Women's Clinical Research - Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103

United States

Nexgen Research

Lima, Ohio, 45801

United States

Jackson Clinic

Jackson, Tennessee, 38305

United States

TMC Life Research, Inc

Houston, Texas, 77054

United States

National Clinical Trials - VA

Reston, Virginia, 20190

United States

Collaborators and Investigators

Sponsor: pH-D Feminine Health LLC

Clinical Trial Manager, STUDY_CHAIR, Medpace GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-08

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Vulvovaginal Candidiases
VVC

Additional Relevant MeSH Terms

Vulvovaginal Candidiases
Vulvovaginal Candidiasis, Genital
Vulvovaginal Candidiasis (VVC)