Recent developments highlight the completion of a clinical study evaluating the safety and performance of Lactal Gel, a Class IIa medical device indicated for the treatment of bacterial vaginosis. This update offers valuable insights for clinical, regulatory, and quality assurance professionals.
Bacterial vaginosis, a common condition, has significant implications for women’s health. Lactal Gel, developed by Rolf Kullgren AB, underwent rigorous investigation in this study, supported by Analyze & Realize.
In this article
- What changed?
- Key findings from the clinical trial
- What is Lactal Gel?
- FAQ
- Conclusion
- Disclaimer
- Announcement link
What changed?
The clinical study evaluating Lactal Gel for treating bacterial vaginosis has been marked as completed. The study explored the safety and efficacy of the product, aligning with regulatory standards for Class IIa medical devices. This conclusion is significant for healthcare providers and regulatory authorities monitoring innovations in this treatment domain.
Key findings from the clinical trial
While specific clinical data were not disclosed in the source, the completion of the trial underscores a key step in evaluating the intended purpose, clinical performance, and safety of Lactal Gel. Notably:
- Lactal Gel is positioned as a non-invasive therapeutic option for bacterial vaginosis management.
- The gel’s formulation is aimed to support the natural vaginal microbiome, reducing the symptoms associated with bacterial vaginosis.
Sponsors Rolf Kullgren AB and Analyze & Realize likely collaborated to ensure compliance with clinical evaluation requirements per medical device regulations.
Further details may be available in the official study results documentation linked below.
What is Lactal Gel?
Lactal Gel is categorized as a Class IIa medical device. It is intended to treat bacterial vaginosis, characterized by an imbalance in vaginal flora. The device works by creating an environment conducive to restoring natural pH levels, promoting normalization of the microbiome.
The gel’s composition and intended purpose reflect structured pre-market assessments, in line with clinical evidence expectations under MDR Annex XIV requirements. Devices in this category require compliance with stringent safety, biocompatibility, and efficacy protocols.
FAQ
- What is bacterial vaginosis?
Bacterial vaginosis is a condition caused by an imbalance in vaginal bacteria, leading to symptoms such as discharge and odor. It is a common yet treatable health issue. - What type of device is Lactal Gel?
Lactal Gel is a Class IIa medical device regulated for treating bacterial vaginosis. - Who sponsored the study?
The study was sponsored by Rolf Kullgren AB and Analyze & Realize.
Conclusion
The completion of this clinical trial is a critical milestone in evaluating the safety and effectiveness of Lactal Gel for bacterial vaginosis. Regulatory and clinical teams should monitor any published results to gain insights into the device’s clinical performance and potential market applications. This development reflects ongoing innovation in addressing women’s health concerns through safe, evidence-based medical devices.
Disclaimer
This post is informational and for healthcare and regulatory professionals. It does not represent legal or clinical advice. Always refer to official documentation and consult regulatory guidelines for decisions.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07241871?term=medical+device