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RecruitingNCT07257770Updated Feb 13, 2026

Local Treatment of Breast Pain Based on the Daily Use of a Topical Gel

An interventional study of inositol in Mastalgia, sponsored by Lo.Li.Pharma s.r.l. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Lo.Li.Pharma s.r.l · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

The trial aims to investigate the effect of a topical application of a medical device based on inositol in recovering breast pain

Read the detailed description

The present study enrolled patients with breast pain (measured through the VAS) aiming to evaluate the improvement of the pain after the local treatment

02

Conditions studied

  • Mastalgia

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Keywords

  • inositol
  • breast pain
  • mastalgia
03

In context

Mastodynia

44 studies on the registry are indexed under Mastodynia; 10 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 37 interventional studies indexed under Mastodynia.

Browse Mastodynia studies →

Lead sponsor

Lo.Li.Pharma s.r.l is the lead sponsor of 30 studies on the registry; 3 are open to participants now.

Browse Lo.Li.Pharma s.r.l studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women aged between 18 and 70 years
  • Women who underwent breast surgery at least 15 days prior
  • Women experiencing breast pain associated with the surgical wound

Exclusion criteria

Exclusion Criteria:

  • Women under the age of 18
  • Ongoing systemic and/or local pain therapy
  • Pregnant women
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • No intervention
    Control

    No treatment, clinical follow up

  • Experimental
    treatment inositol

    daily administration of the gel

    Device: inositol

Interventions

  • Deviceinositol

    Topical application of a medical device based on inositol

06

What researchers measure

Primary outcomes

  1. Reduction of breast pain

    Breast pain is evaluated by using VAS (Visual Analogue Scale)

    Time frame: 3 months

Secondary outcomes

  1. Follow up breast pain

    Breast pain is evaluated by using VAS (Visual Analogue Scale)

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07257770
Lead sponsor
Lo.Li.Pharma s.r.l
Responsible party
Sponsor
First posted
Dec 2, 2025
Start date
Sep 11, 2025
Primary completion
Apr 11, 2026 (estimated)
Completion
Jul 11, 2026 (estimated)
Last update
Feb 13, 2026

Study contacts

Maria Ida Amabile
Contact
mariaida.amabile@uniroma1.it
+393290847775

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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