MastalgiaNCT07257770
Local Treatment of Breast Pain Based on the Daily Use of a Topical Gel
A study testing inositol in people with Mastalgia, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
The trial aims to investigate the effect of a topical application of a medical device based on inositol in recovering breast pain Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Mastalgia
- What is being tested?
- inositol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 11 Sep 2025to 11 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women under the age of 18
- Ongoing systemic and/or local pain therapy
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Effect of a Medical Device Based on Inositol in Improving Breast Pain
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
- Conditions
- Mastalgia
- Being tested
- inositol
- Keywords
- inositol, breast pain, mastalgia
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inositolDevice
Topical application of a medical device based on inositol
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No treatment, clinical follow up |
| treatment inositol | Experimental | daily administration of the gel Receives: Device: inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of breast pain
Breast pain is evaluated by using VAS (Visual Analogue Scale)
Measured: 3 months
Secondary outcomes (1)
Follow up breast pain
Breast pain is evaluated by using VAS (Visual Analogue Scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start11 Sep 2025
- Primary completion11 Apr 2026 (estimated)
- Study completion11 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257770
- Sponsor's protocol ID
- INO-BREAST
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of a Medical Device Based on Inositol in Improving Breast Pain
- ClinicalTrials.gov ID
- NCT07257770
- Acronym / sponsor ID
- INO-BREAST
- Conditions
- Mastalgia
- Keywords
- inositol, breast pain, mastalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 11 Apr 2026 (estimated)
- Study completion
- 11 Jul 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial aims to investigate the effect of a topical application of a medical device based on inositol in recovering breast pain
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No treatment, clinical follow up |
| treatment inositol | Experimental | Device: inositoldaily administration of the gel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Women under the age of 18
- Ongoing systemic and/or local pain therapy
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inositolTopical application of a medical device based on inositol | Device | treatment inositol |
Primary outcome
Reduction of breast pain
Time frame: 3 months
Breast pain is evaluated by using VAS (Visual Analogue Scale)
1 secondary outcome
Follow up breast pain
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inositol in people with Mastalgia, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Ida Amabile (+393290847775, mariaida.amabile@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of breast pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.