Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    36
  • sponsor
    Fudan University
Updated on 1 September 2021
fasting
adjunctive treatment
lipoprotein cholesterol
low-density lipoprotein
blood lipid
megestrol acetate
hysteroscopy
high-density lipoprotein
atypical endometrial hyperplasia

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.

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-mllerian 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.

Details
Condition Disorder of uterus NOS, Endometrial Hyperplasia, Uterine Disorders, atypical endometrial hyperplasia
Treatment Rosuvastatin, Megestrol Acetate
Clinical Study IdentifierNCT04491682
SponsorFudan University
Last Modified on1 September 2021

Eligibility

Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note