A new clinical trial examining a topical gel for breast pain has been announced, with recruitment now underway. Sponsored by Lo.Li.Pharma s.r.l., the study will evaluate the safety and efficacy of a device containing inositol, targeting individuals suffering from mastalgia. This development may interest clinical teams, regulatory experts, and medical device professionals working in women’s health.
In this article:
- What changed?
- What are the study details?
- What is the potential clinical impact?
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Announcement and link
What changed?
On December 3, 2025, Lo.Li.Pharma s.r.l commenced recruitment for a clinical trial aimed at addressing mastalgia using a novel topical gel containing inositol. Mastalgia is a common form of breast pain that can significantly affect quality of life. The study emphasizes the manufacturer’s commitment to advancing non-invasive treatment options for this condition.
What are the study details?
Study overview
The trial is listed on ClinicalTrials.gov under the identifier NCT07257770. Participants will use the inositol-based topical gel as part of the study protocol to assess its impact on breast pain symptoms. While the full methodology is yet to be detailed publicly, the focus is on safety, efficacy, and the practicality of daily use of the gel.
Device description
The study centers on a medical device using inositol, a compound demonstrated to have potential benefits in cell signaling and hormonal modulation. Lo.Li.Pharma describes the gel as non-invasive, making it an appealing alternative for mastalgia management compared to systemic therapies that may carry greater side-effect risks.
Sponsor details
Lo.Li.Pharma s.r.l specializes in developing medical solutions targeting underserved health concerns. Its sponsorship of this study aligns with its broader mission to innovate within the women’s health space.
What is the potential clinical impact?
Implications for treatment
If successful, the trial could lead to increased adoption of non-pharmaceutical interventions for mastalgia, providing a safe, patient-friendly option. This has regulatory and clinical significance, as it broadens available management tools.
Considerations for approval
To meet regulatory requirements, the sponsor will collect and analyze robust data ensuring the gel’s compliance with medical device standards. Clinical professionals should monitor outcomes for performance benchmarks aligned with MDR Annex XIV and other applicable regulations.
Frequently Asked Questions
- What is mastalgia?
Mastalgia refers to breast pain, which may be cyclical or non-cyclical, and is often related to hormonal fluctuations. - How is inositol used?
Inositol in the topical gel is thought to impact cell signaling and hormones, potentially reducing mastalgia symptoms. - Is the gel available for patients?
Currently, the gel is under clinical evaluation and is not yet commercially available.
Conclusion
The initiation of this clinical trial represents a step forward in developing effective mastalgia treatments. Medical device teams and regulatory professionals should monitor its progress for potential impacts on clinical practice and future device approvals.
Disclaimer
This content is for informational purposes only and does not constitute legal or medical advice. Professionals should consult regulatory standards and clinical sources directly.
Announcement and link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07257770?term=medical+device