Clinical trial NCT04491682: Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
Official title: Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atypical Endometrial Hyperplasia
Keywords: megestrol acetate
rosuvastatin
atypical endometrial hyperplasia
conservative treatment
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To see if megestrol acetate plus rosuvastatin will be superior to reversing the endometrial lesion to a normal endometrium than megestrol acetate alone in patients with atypical endometrial hyperplasia (AEH). Considering the large sample size in RCT, we used Simon two-stage design.

Detailed description: After diagnosed of AEH by hysteroscopy, patients will be enrolled. Age, height, weight, waist circumstances, blood pressure, basic history of infertility and blood pressure will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), OGTT 2h blood glucose and insulin, blood lipids, SHBG, sex hormone levels, anti-müllerian hormone(AMH), creatine kinase(CK) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 520.

Patients are randomized to 1 of 2 treatment groups. Patients will receive MA 160 mg plus rosuvastatin 10mg by mouth daily for at least 6 months. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. Complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. Continuous therapies will be needed in PR or NR. Patients with PD will be recommended for hysterectomy.

Two months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.

Eligibility criteria: Inclusion Criteria:

* Have a confirmed pathological diagnosis based upon hysteroscopy
* 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 statins
* 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)

Primary outcomes:
measure: Pathological response rate
timeFrame: 12 to 16 weeks
Secondary outcomes:
measure: Pathological response rate
timeFrame: 28 to 32 weeks
measure: Pathological response duration
timeFrame: Up to 2 years
measure: Pathological response rate classified by different blood lipid level
timeFrame: Up to 32 weeks
measure: Toxicity evaluation
timeFrame: Up to 32 weeks
measure: Relapse rate
timeFrame: up to 2 years after the therapy for each patient
measure: Pregnancy rate
timeFrame: up to 2 years after the therapy for each patient
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital, Fudan University
Study officials:
affiliation: Obstetrics and Gynecology Hospital, Fudan University
name: Xiaojun Chen
role: PRINCIPAL_INVESTIGATOR
References: