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NCT07109869RECRUITINGIRB Ready

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

Sponsored by pH-D Feminine Health LLC

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 201 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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 Can Participate

Inclusion Criteria

Patients who are postmenarcheal, nonpregnant biological females, 12 years of age and older, at Screening; 2. Patients with acute symptomatic VVC infection at Screening, defined as meeting all of the following criteria:
A potassium hydroxide (KOH) wet mount or saline preparation performed from the inflamed vaginal mucosa or secretions demonstrating yeast forms (hyphae or pseudohyphae) of budding yeast;
Vaginal pH โ‰ค4.5; and
Total Vulvar Signs and Symptoms (VSS) Scale score of โ‰ฅ4: vulvovaginal signs (edema, erythema, and excoriation/fissures) and symptoms (vulvovaginal burning, itching, and irritation) as rated using the VSS Scale. 3. 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 or clinically insignificant findings not requiring any further surveillance or treatment beyond a rep

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

201 participants

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Gender

FEMALE

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Sponsor

pH-D Feminine Health LLC

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Mobile

Alabama

Location available
View Mobile location page
WITHDRAWN

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Huntington Park

California

Location available
View Huntington Park location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page

๐Ÿ“ And 11 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Yeast Infection Treatment in Mobile?

Join others in Alabama exploring innovative treatment options through clinical research

Yeast Infection Treatment Options in Mobile, Alabama

If you're searching for Yeast Infection treatment in Mobile, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Mobile, Phoenix, Huntington Park and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Yeast Infection. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 201 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Yeast Infection?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Yeast Infection

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Yeast Infection Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07109869. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.