A clinical study has been initiated to evaluate the safety and efficacy of Multi-Gyn FemiTotal, a medical device developed for the treatment and prevention of bacterial vaginosis and vaginal candidiasis. Sponsored by Karo Pharma AB, the study is actively recruiting participants as of November 2025. This development may interest clinical, quality, and regulatory professionals monitoring advancements in medical devices for gynecological health.
What changed?
The clinical investigation marks a significant step for Karo Pharma AB’s Multi-Gyn FemiTotal, specifically targeting two common vaginal infections: bacterial vaginosis and vaginal candidiasis. Both conditions impact millions worldwide and require effective interventions. The study may provide critical data to support the device’s performance and safety claims in line with regulatory standards.
About the study
As detailed on ClinicalTrials.gov, the study focuses on testing the vaginal gel under real-world conditions. The intended outcomes include evaluating the gel’s ability to treat active infections and its preventive efficacy. Recruitment details are publicly available, enabling eligible participants to contribute to the research. Regulatory teams and clinical stakeholders will closely scrutinize the device’s outcomes for future approvals and wider market applications.
Focus on female health
The study addresses two prevalent conditions:
- Bacterial vaginosis (BV): BV is caused by an imbalance in vaginal bacteria, leading to symptoms such as abnormal discharge and odor. It is the most common vaginal condition in women of reproductive age.
- Vaginal candidiasis: This is a fungal infection caused by Candida yeast, resulting in itching, irritation, and sometimes painful discharge. It frequently affects women and is a significant healthcare burden.
How does Multi-Gyn FemiTotal work?
Multi-Gyn FemiTotal is a medical device designed to support vaginal health by restoring balance to the vaginal microbiota. It reportedly combines active properties to reduce symptoms and prevent recurrence. While this trial will gather the safety and efficacy data needed to confirm its performance, existing insights suggest its mechanism targets both infection treatment and prevention.
Karo Pharma AB, the device’s sponsor, emphasizes its potential as a dual-purpose product. Devices with such intended uses often provide critical alternatives to pharmaceutical treatments, presenting fewer risks of systemic side effects.
FAQ
- 1) What is the expected duration of the study?
The source did not specify timelines, but clinical studies of this nature often span several months. - 2) How can individuals enroll in the study?
Recruitment information is available on ClinicalTrials.gov under study ID NCT07234786. - 3) Is Multi-Gyn FemiTotal already on the market?
This clinical investigation aims to generate supporting data for wider regulatory approvals and applications.
Conclusion
The clinical evaluation of Multi-Gyn FemiTotal signals progress in the gynecological medical device sector. With bacterial vaginosis and vaginal candidiasis being pervasive challenges, this device could offer a meaningful solution if successfully validated. Clinical, quality, and regulatory professionals should follow this study for insights into the evolving standards of gynecological care.
Disclaimer
This content is for informational purposes only and does not constitute legal or clinical advice. Always consult regulatory guidelines or a legal professional for compliance matters.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07234786?term=medical+device