NCT07257770

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Sep 2025Jul 2026

Study Start

First participant enrolled

September 11, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2026

Expected
Last Updated

February 13, 2026

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 19, 2025

Last Update Submit

February 12, 2026

Conditions

Mastalgia

Keywords

inositolbreast painmastalgia

Outcome Measures

Primary Outcomes (1)

  • Reduction of breast pain

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

    3 months

Secondary Outcomes (1)

  • Follow up breast pain

    6 months

Study Arms (2)

Control

NO INTERVENTION

No treatment, clinical follow up

treatment inositol

EXPERIMENTAL

daily administration of the gel

Device: inositol

Interventions

inositolDEVICE

Topical application of a medical device based on inositol

treatment inositol

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale - breast pain
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Umberto I

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Mastodynia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Maria Ida Amabile

CONTACT

+393290847775mariaida.amabile@uniroma1.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 2, 2025

Study Start

September 11, 2025

Primary Completion

April 11, 2026

Study Completion (Estimated)

July 11, 2026

Last Updated

February 13, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)