Megestrol Acetate Plus Rosuvastatin in Young Women with Early Endometrial Carcinoma

Last updated: March 10, 2025
Sponsor: Fudan University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Endometrial Cancer

Carcinoma

Treatment

Megestrol Acetate

Rosuvastatin

Clinical Study ID

NCT04491643
53211029-02
  • Ages 18-45
  • Female

Study Summary

To explore the treatment efficacy of megestrol acetate plus rosuvastatin in patients with early endometrial carcinoma (EEC) seeking for conservative treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a confirmed pathological diagnosis based upon hysteroscopy: histologicallyprove well-differentiated EEC G1 without myometrial invasion

  • No signs of suspicious extrauterine involvement on enhanced magnetic resonanceimaging (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

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 thrombosisdisease

  • 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)

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Megestrol Acetate
Phase: 2
Study Start date:
September 01, 2020
Estimated Completion Date:
April 11, 2025

Study Description

After diagnosed of EEC by hysteroscopy, patients meet the study criteria 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 will receive MA (megestrol acetate) 160 mg by mouth daily 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 hyperplasia with or without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of higher pathological progression, or myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR or NR. Patients with PD will be recommended for hysterectomy.

Due to personal reasons, patients may not accept hysteroscopic evaluation every three months, then the longest duration will be 8 months. For patients remained SD after 6 to 8 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given.

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

Connect with a study center

  • Obstetrics and Gynecology Hospital, Fudan University

    Shanghai,
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.