Clinical trial · Interventional
Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma
NCT04491643CI-TRIAL-00093446completedPhase 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 megestrol acetate plus rosuvastatin in patients with early endometrial carcinoma (EEC) seeking for conservative treatment.
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 Carcinoma Stage I | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Megestrol Acetate | Drug | Megestrol | ALIAS |
| Rosuvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MA + Rosuvastatin
- description
- Patients will receive MA 160 mg and rosuvastatin 10 mg by mouth daily for at least 6 months. Then every 3 months, hysteroscopy will be used to evaluate the endometrial condition, and findings will be recorded. Due to personal reasons, patients may not accept hysteroscopic evaluation every three months, then the longest duration will be 8 months.
- interventionNames
- Drug: Megestrol Acetate
- Drug: Rosuvastatin
Primary outcomes (1)
- measure
- Pathological response rate
- timeFrame
- 12 to 16 weeks
- description
- From date of initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion * 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 * Abnormal blood lipid. At least meet one of the following five items: 1. Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL) 2. Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL) 3. Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL) 4. High-density lipoprotein cholesterol (HDL-C) \< 1.03mmol/L (40mg/dL) 5. Apo-lipoprotein-A (Apo-A) \< 1.0g/L Exclusion Criteria: * Acute liver disease or liver tumor (benign or malignant) or renal dysfunction * Pregnancy or potential pregnancy * Under treatment of high-dose progestin therapy more than 1 months in recent 6 months * Confirmed diagnosis of any cancer in reproductive system * Acute severe disease such as stroke or heart infarction or a history of thrombosis disease * Hypersensitivity or contradiction for using MA or atorvastatin * Already diagnosed with hyperlipidemia and using lipid-lowering drugs * 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.