22 Participants Needed

Lactic Acid Gel for Vaginal Infections

OH
Overseen ByOlivia H Manayan, MD, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: Queen's Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12367

Who Is on the Research Team?

OM

Olivia Manayan, MD, MPH

Principal Investigator

University of Hawaii

BK

Bliss Kaneshiro, MD, MPH

Principal Investigator

Queen's Medical Center

CM

Corrie Miller, DO

Principal Investigator

University of Hawaii

Are You a Good Fit for This Trial?

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.
See 2 more

Exclusion Criteria

I currently have a urinary tract infection (UTI).
Pregnant or trying to become pregnant
I have gone through menopause.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Study groupExperimental Treatment1 Intervention

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Phexxi for:

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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.
Studies on gynaecological hydrophilic lactic acid preparations, Part 7: use of chitosan as lactic acid carrier in intravaginal tablets (globuli vaginales).Maล‚olepsza-Jarmoล‚owska, 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.
Studies on gynecological hydrophilic lactic acid preparations. Part 8: use of chitosan as lactic acid carrier in intravaginal tablets.Maล‚olepsza-Jarmoล‚owska, K.[2013]

Citations

Lactacyd FH as an adjuvant therapy for vulvovaginal infections in Pakistani women: FRESH study, a satisfaction survey. [2017]
Studies on gynaecological hydrophilic lactic acid preparations, Part 7: use of chitosan as lactic acid carrier in intravaginal tablets (globuli vaginales). [2013]
Studies on gynecological hydrophilic lactic acid preparations. Part 8: use of chitosan as lactic acid carrier in intravaginal tablets. [2013]
[Study of a new lactic acid and pH 5.2 lactoserum emulsion for feminine hygiene. Results of a clinical study]. [2013]
Evaluation of vaginal malodor and efficacy of treatment by high performance ion exchange chromatography. [2016]
Vaginal pH and microbicidal lactic acid when lactobacilli dominate the microbiota. [2023]
Bacterial vaginosis and the effect of intermittent prophylactic treatment with an acid lactate gel. [2018]
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