Clinical trial · Interventional
Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
NCT04792749CI-TRIAL-00065613unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to investigate the effects of metformin in addition to the conventional progestin therapy in the fertility-sparing treatment of early stage endometrial cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer Stage I | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin treatment
- description
- Patients who receive metformin in addition to progestin therapy
- interventionNames
- Drug: Metformin
- type
- NO_INTERVENTION
- label
- Conventional treatment
- description
- Patients who receive progestin therapy only
Primary outcomes (4)
- measure
- Treatment response rates
- timeFrame
- 3 months after the initiation of the treatment
- description
- Measurements of the primary lesion by the RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Endometrial cancer radiologic International Federation of Obstetrics and Gynecology (FIGO) stage IA patients * Endometrioid endometrial cancer patients * FIGO cellular differentiation grade 1 patients * Patients who wish to preserve fertility * Patients who understand that the recommended treatment of endometrial cancer is surgical treatment even in early stages, but still wish to preserve fertility and avoid surgical treatment * Patients who have good performance status (Eastern Cooperation Oncology Group (ECOG) performance score equal to or greater than 3) * Patients who are not contraindicated to the progestin therapy * Patients who are not contraindicated to the use of metformin Exclusion Criteria: * Patients who have already received chemotherapeutic or radiotherapeutic treatments for endometrial cancer * Patients whose disease is already advanced and not indicated for fertility-sparing treatment * Patients whose tumor cellular differentiation grade is greater than FIGO grade 1
References
Publications (0)
Data not yet available
No reference posted for this study.