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Completed

NCT Number: NCT04491682

Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)
  • Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL)
  • Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL)
  • High-density lipoprotein cholesterol (HDL-C) < 1.03mmol/L (40mg/dL)
  • 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)

Treatment and study plan

Megestrol acetate

Drug

At a dosage of 160 mg/day

Rosuvastatin

Drug

At a dosage of 10 mg/day

Primary outcomes

  1. Pathological response rate

    Time frame: 12 to 16 weeks

    From date of randomization or initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks.

Secondary outcomes

  1. Pathological response rate

    Time frame: 28 to 32 weeks

    From date of randomization or initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 32 weeks.

  2. Pathological response duration

    Time frame: Up to 2 years

    Pathological response duration

  3. Pathological response rate classified by different blood lipid level

    Time frame: Up to 32 weeks

    Pathological response rate classified by different blood lipid level

  4. Toxicity evaluation

    Time frame: Up to 32 weeks

    Toxicity evaluation according to CTCAE 5.0 version.

  5. Relapse rate

    Time frame: up to 2 years after the therapy for each patient

  6. Pregnancy rate

    Time frame: up to 2 years after the therapy for each patient

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2020
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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