Clinical trial · Interventional
Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
NCT05675787CI-TRIAL-00078758unknownPhase 2ClinicalTrials.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)
To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Endometrial Hyperplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Endometrial Carcinoma Stage I | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medroxyprogesterone acetate + Atorvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- MPA + Atorvastatin
- interventionNames
- Drug: Medroxyprogesterone acetate + Atorvastatin
- type
- NO_INTERVENTION
- label
- Control groups
- description
- MPA
Primary outcomes (1)
- measure
- Pathological cumulative complete response rate;
- timeFrame
- assessed up to 4 months
- description
- 3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 17 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy; * No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound * Have a desire for remaining reproductive function or uterus * Good compliance with adjunctive treatment and follow-up Exclusion Criteria: * Hypersensitivity or contradiction for using MPA or atorvastatin * Pregnancy or potential pregnancy * Confirmed diagnosis of any cancer in reproductive system * Already diagnosed with hyperlipidemia and using lipid-lowering drugs * Acute liver disease or liver tumor (benign or malignant) or renal dysfunction * Acute severe disease such as stroke or heart infarction or a history of thrombosis disease * With other factors of reproductive dysfunction; * Strong request for uterine removal or other conservative treatment * Smoker (\>15 cigarettes a day) * Drinker (\>20 grams a day)
References
Publications (0)
Data not yet available
No reference posted for this study.