Women's Health Formulation for Vaginal Health

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Cardiac dysfunction, Liver disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how a women's health formulation, referred to as the Active Product, can improve vaginal health and balance vaginal bacteria. It seeks participants in the United States who want better vaginal health. Ideal candidates should have noticeable room for improvement in their vaginal health and be willing to provide a vaginal sample twice.

As an unphased trial, this study offers participants the chance to contribute to important research in women's health.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with the study product. This includes medications like anticoagulants, antidepressants, and others listed in the trial's exclusion criteria. It's best to discuss your current medications with the trial team to see if any changes are needed.

What prior data suggests that this women's health formulation is safe for vaginal health?

Research has shown that hormone treatments for menopause, like the one under study, are considered safe. The FDA recently removed a strong warning about serious risks such as breast cancer and heart attacks from these treatments. This change is based on new scientific evidence supporting their safety. The product in this study is expected to be similarly safe. However, participants should always inform the study team about any side effects experienced. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Women's Health Formulation for Vaginal Health because it offers a new approach to improving vaginal health. Unlike existing treatments that often rely on antibiotics or antifungal agents to tackle infections, this experimental product potentially introduces a unique mechanism or ingredient focused on promoting overall vaginal health, rather than solely addressing infections. This could lead to broader benefits, such as improved comfort and balance in the vaginal environment, with fewer side effects commonly associated with conventional treatments.

What evidence suggests that this treatment might be an effective treatment for vaginal health?

Research has shown that products designed for women's health can positively affect vaginal health. For instance, one study found that women using products with natural plant extracts experienced noticeable improvements in their vaginal health within four weeks. The community of microbes in the vagina, known as the vaginal microbiome, plays a crucial role in maintaining vaginal health. Improving this balance with supplements might lead to better health outcomes. Early results suggest that the active product tested in this trial may support a healthy balance of these microbes. These findings offer hope for those considering joining the trial. ^{1 6 7 8 9}

Who Is on the Research Team?

Susan Hewlings

Principal Investigator

Radicle Science Inc.

Are You a Good Fit for This Trial?

This trial is for women interested in improving their vaginal health. Specific eligibility criteria are not provided, but typically participants would need to be in good general health with an interest or need to enhance their vaginal microbiome.

Inclusion Criteria

I want to improve my vaginal health.

Resides in the United States

I am a woman aged 21-65 and ready to give electronic consent.

Exclusion Criteria

Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)

Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products

I haven't had a urinary tract infection in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the women's health formulation and report health indicators electronically

5 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Product

Trial Overview The study is testing the effects of a new women's health formulation on vaginal health and its impact on the microbial community within the vagina. It's an open-label study, meaning both researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: Active Product Experimental Treatment 1 Intervention

Women's (vaginal) health active product

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07036666

A Study Assessing the Impact of a Women's Health ... Has the opportunity for at least 30% improvement in their primary health outcome (i.e., Vaginal Health Survey score ≥ 14 at screening) ... Women's (vaginal) ...

2. patlynk.com patlynk.com/trial/NCT07036666

Women's Health Formulation's Impact on Vaginal Health ... This study aims to evaluate how a specific women's health supplement affects vaginal health and the community of microbes in the vagina.

3. gcgh.grandchallenges.org gcgh.grandchallenges.org/challenge/accelerating-innovation-vaginal-formulations-support-womens-health

Innovation in Vaginal Formulations in Women's Health We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7789027/

Role of female intimate hygiene in vulvovaginal health In a large study during which women were asked to use feminine wash products containing natural plant extracts for 4 weeks, a positive clinical effect was shown ...

5. gov.uk gov.uk/government/news/new-review-highlights-untapped-potential-of-the-vaginal-microbiome-in-womens-health

New review highlights untapped potential of the vaginal ... The vaginal microbiome is a largely overlooked area of medicine that could dramatically improve outcomes for millions of women, ...

6. statnews.com statnews.com/2025/11/10/fda-reverses-hormone-warning-menopause-health/

FDA ends hormone therapy warning, says safe ... - STAT News FDA removes black box warning on hormone therapy, reflecting new science on menopause, heart health, and evolving views on women's care.

7. nbcnews.com nbcnews.com/health/womens-health/hormone-replacement-therapy-no-warning-label-fda-rcna243008

Hormone replacement therapy will no longer carry a ... Hormone therapies for menopause will no longer carry a black box warning about serious risks such as breast cancer, heart attack and stroke, ...

8. contemporaryobgyn.net contemporaryobgyn.net/view/fda-initiates-removal-of-boxed-warnings-from-hormone-therapy-for-menopause

FDA initiates removal of boxed warnings, requests updated ... FDA updates labeling for menopausal hormone therapy, removing broad boxed warnings and adding guidance for younger symptomatic patients.

9. cnn.com cnn.com/2025/11/10/health/hormone-therapy-menopause-fda-warning-wellness

'Black box' safety warning to be removed from hormone ... Women's health experts praised the move to update the boxed warning to reflect newer scientific evidence around menopausal hormone therapy ...