Trial · NCT06404775
External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women with Severe Mastalgia
NCT06404775, Phase 3, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women with Severe Mastalgia. Trials, record NCT06404775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06404775
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women with Severe Mastalgia
- NCT number
- NCT06404775
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 456 participants, estimated
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Conditions
- Mastalgia
- Interventions
- mastalgia-oil, tamoxifen placebo, mastalgia-oil placebo, tamoxifen
- First posted
- 2024-05-08
- Last updated
- 2024-11-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mastalgia clinical response rate | Within 4 weeks after the end of the third treatment menstrual cycle | The recruited patients with mastalgia will be asked to record their symptoms of breast pain using a daily VAS breast pain chart, and the sum of the daily VAS within a menstrual cycle is considered the breast pain score (BPS). Effective rate (%)= \[BPS (P) - BPS (T3)\]/BPS (P)\*100%, where BPS (P) indicates BPS of the placebo lead-in cycle and BPS (T3) indicates BPS at the end of the third treatment cycle. An effective rate of more than 50% is considered a clinical response. |
| Primary | Safety (adverse events) | from signing the informed consent form until 4 weeks after the end of the third treatment menstrual cycle | Total incidence of the following adverse events: hot flashes + leukorrhea + menorrhagia + nausea + headache + skin reactions. Adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).Each patient will be counted only once for the above adverse events experienced. |
| Secondary | Subgroup mastalgia clinical response rate | Within 4 weeks after the end of the third treatment menstrual cycle | Mastalgia clinical response rate in women with cyclical mastalgia; Mastalgia clinical response rate in women with non-cyclical mastalgia |
| Secondary | Breast nodularity | Within 7 days before the first treatment and the end of each treatment menstrual cycle | Breast nodularity will be assessed according to the Lucknow-Cardiff breast nodularity scale.The above breast nodularity scale is a 5-point ordinal scale depicting increasing order of nodularity in upper outer quadrants of the breasts. Grade-0 depicts a smooth textured breast with extreme extent of normalcy and grade-4 the maximum nodularity. |
| Secondary | Pharmacokinetics of mastodynia-oil | Within 4 weeks after the end of the third treatment menstrual cycle | Collection of blood samples for pharmacokinetic trough concentration-effect analysis of mastodynia-oil |
| Secondary | Changes in blood biochemical indicators | Within 4 weeks after the end of the third treatment menstrual cycle | Tamoxifen-specific indicators: estradiol, progesterone, et al. and their correlation with the primary endpoints were detected in blood before and after treatment using ELISA. |
| Secondary | Changes in blood metabolites | Within 4 weeks after the end of the third treatment menstrual cycle | Comparison of changes in blood metabolites before and after treatment and their correlation with primary endpoints using metabolomics. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20223665 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06404775
GET https://conductscience.org/api/trials/v1/NCT06404775/registered