Lactic Acid Gel for Vaginal Infections

Overseen By Olivia H Manayan, MD, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Queen's Medical Center

Disqualifiers: Pregnant, Post-menopausal, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using Phexxi as a contraceptive, you cannot participate in the study.

What data supports the effectiveness of the treatment Phexxi, Lactic Acid, Citric Acid, and Potassium Bitartrate for vaginal infections?

Research shows that lactic acid, a component of the treatment, can help maintain a healthy vaginal pH and support normal flora, which is important for preventing infections. Additionally, lactic acid preparations have been shown to neutralize excess alkali in severe vaginal infections, suggesting potential effectiveness in treating such conditions. ^{1 2 3 4 5}

How is the drug Phexxi different from other treatments for vaginal infections?

Phexxi is unique because it combines lactic acid, citric acid, and potassium bitartrate to maintain an acidic environment in the vagina, which helps prevent infections. Unlike antibiotics, it works by restoring the natural acidity and promoting the growth of healthy bacteria, offering a non-antibiotic option for managing vaginal infections. ^{1 2 3 6 7}

Research Team

Olivia Manayan, MD, MPH

Principal Investigator

University of Hawaii

Bliss Kaneshiro, MD, MPH

Principal Investigator

Queen's Medical Center

Corrie Miller, DO

Principal Investigator

University of Hawaii

Eligibility Criteria

This trial is for pre-menopausal females aged 18-54 who have had at least two episodes of BV or candida infection in the past year. Participants must speak English and be able to consent. Those with current UTIs, pregnancy, post-menopause status, NuvaRing use, kidney issues, or using Phexxi are excluded.

Inclusion Criteria

I am female.

You are proficient in both verbal and written English.

I've had at least 2 yeast or BV infections in the last year that needed treatment.

Exclusion Criteria

I currently have a urinary tract infection (UTI).

Pregnant or trying to become pregnant

I have gone through menopause.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Assessment and classification of patients' vaginal microbiome prior to receipt of the intervention

1 week

Self-collection at home

Treatment

Participants use Phexxi twice per week for 30 days, with self-collection of samples and diary keeping

4 weeks

Self-collection at home

Post-Treatment Assessment

NextGen analysis and survey to assess changes in vaginal microbiome and symptoms immediately after intervention

1 week

Self-collection at home

Follow-up

Participants are monitored for changes in vaginal microbiome and symptoms 30 days post-intervention

4 weeks

Self-collection at home

Treatment Details

Interventions

• Phexxi

Trial Overview The study tests if Phexxi (an intravaginal contraceptive gel) alters the vaginal microbiome by promoting lactic acid-producing lactobacilli growth. This could potentially help prevent recurrent bacterial vaginosis and yeast infections.

Participant Groups

Group I: Study group Experimental Treatment 1 Intervention

This is a single-arm study. all participants are assigned to this arm. all study participants will receive Phexxi, the study drug. 8 pre-filled vaginal inserters with vaginal gel, Phexxi, will be provided to each of the participants with verbal and written instructions for application. Patients will be instructed to use Phexxi twice per week, on the same days every week.

Phexxi is already approved in United States for the following indications:

Approved in United States as Phexxi for:

• Birth Control

Who Is Running the Clinical Trial?

Queen's Medical Center

Lead Sponsor

Trials

24

Recruited

4,900+

University of Hawaii Foundation

Collaborator

Trials

2

Recruited

60+

Findings from Research

In a study involving 919 women with vulvo-vaginal infections, the adjuvant therapy of lactic acid+lactoserum provided significant symptomatic relief, with 80.1% of patients reporting reduced malodour and 78.5% experiencing less itching by the fourth day of use.

The treatment was well-tolerated, with 91.3% of patients finding it gentle on the skin and no adverse events reported, indicating a high level of safety and patient satisfaction (88.6%) with the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactacyd FH as an adjuvant therapy for vulvovaginal infections in Pakistani women: FRESH study, a satisfaction survey. Eusaph, AZ., Nighat, R., Arshad, A.[2017]

Intravaginal tablets made from hydrophilic methylcellulose and containing lactic acid and chitosan can effectively form a gel that adheres to the vaginal mucosa, providing a durable dosage form for treatment.

By adjusting the ratio of lactic acid to chitosan, these tablets can maintain a physiological pH range while also having the ability to neutralize excess alkalinity during severe vaginal infections, enhancing their therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies on gynaecological hydrophilic lactic acid preparations, Part 7: use of chitosan as lactic acid carrier in intravaginal tablets (globuli vaginales). Małolepsza-Jarmołowska, K.[2013]

The study developed hydrophilic intravaginal tablets made from methylcellulose, lactic acid, and chitosan that swell and form a gel at physiological pH, which could provide a durable dosage form for vaginal applications.

By adjusting the ratio of lactic acid to chitosan, the tablets can create gels that not only maintain an optimal pH for vaginal health but also have the potential to neutralize excess alkalinity during severe vaginal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies on gynecological hydrophilic lactic acid preparations. Part 8: use of chitosan as lactic acid carrier in intravaginal tablets. Małolepsza-Jarmołowska, K.[2013]

The lactic acid-based feminine hygiene solution was tested on 40 women over 8 weeks, showing no significant changes in vaginal pH or flora, indicating its safety and tolerability.

Despite two cases of candidiasis during the trial, the vaginal flora returned to normal by the end of the study, suggesting that the product does not disrupt healthy vaginal microbiota.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study of a new lactic acid and pH 5.2 lactoserum emulsion for feminine hygiene. Results of a clinical study]. Jacquet, A., Roussilhes, R., Anoufa, S., et al.[2013]

High performance ion exchange chromatography revealed a significant presence of caproic acid in the vaginal fluid of a woman with persistent foul odor, indicating a potential link to her symptoms.

After treatment with metronidazole, the caproic acid levels decreased and were replaced by lactic acid, suggesting that this method could be effective for diagnosing and monitoring other vaginal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of vaginal malodor and efficacy of treatment by high performance ion exchange chromatography. Stanek, R., Glover, DD., Mya, S., et al.[2016]

In a study of 56 women with a lactobacillus-dominated vaginal microbiota, the average pH of cervicovaginal fluid was found to be 3.5, indicating a more acidic environment than previously reported, which enhances the protective effects against infections.

The concentration of lactic acid was significantly higher than earlier studies suggested, making it a more potent microbicide, thus highlighting the importance of lactobacilli in providing greater protection against reproductive tract infections than previously understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal pH and microbicidal lactic acid when lactobacilli dominate the microbiota. O'Hanlon, DE., Moench, TR., Cone, RA.[2023]

In a study of 42 women with recurrent bacterial vaginosis (BV), treatment with an acid lactate gel significantly reduced BV symptoms, with 88% of women showing clinical improvement compared to only 10% in the placebo group.

The lactate gel also effectively restored normal vaginal flora, with 83% of women in the treatment group reestablishing healthy lactobacilli levels, while only 16% in the placebo group did so, and the treatment was found to be free of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial vaginosis and the effect of intermittent prophylactic treatment with an acid lactate gel. Andersch, B., Lindell, D., Dahlén, I., et al.[2018]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Lactacyd FH as an adjuvant therapy for vulvovaginal infections in Pakistani women: FRESH study, a satisfaction survey. [2017]

2. Germany pubmed.ncbi.nlm.nih.gov

Studies on gynaecological hydrophilic lactic acid preparations, Part 7: use of chitosan as lactic acid carrier in intravaginal tablets (globuli vaginales). [2013]

3. Poland pubmed.ncbi.nlm.nih.gov

Studies on gynecological hydrophilic lactic acid preparations. Part 8: use of chitosan as lactic acid carrier in intravaginal tablets. [2013]

4. France pubmed.ncbi.nlm.nih.gov

[Study of a new lactic acid and pH 5.2 lactoserum emulsion for feminine hygiene. Results of a clinical study]. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of vaginal malodor and efficacy of treatment by high performance ion exchange chromatography. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Vaginal pH and microbicidal lactic acid when lactobacilli dominate the microbiota. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Bacterial vaginosis and the effect of intermittent prophylactic treatment with an acid lactate gel. [2018]