AzTrials
AzTrials

Endometrial Carcinoma Stage IPhase 2NCT04491643

Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma

A Phase 2 study testing Megestrol Acetate and Rosuvastatin in people with Endometrial Carcinoma Stage I, run by Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometrial Carcinoma Stage I
What is being tested?
Megestrol Acetate and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
1 Sep 2020to 11 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
  • Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Obstetrics and Gynecology Hospital, Fudan University

    Shanghai

Other trials in China

About this study

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

Read the detailed 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.

Being tested
Megestrol Acetate, Rosuvastatin
Keywords
megestrol acetate, rosuvastatin, endometrial carcinoma stage I limited to endometrium, conservative treatment
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Megestrol AcetateDrug

    At a dosage of 160 mg/day

  • RosuvastatinDrug

    At a dosage of 10 mg/day

Study groups in NCT04491643
Study groupRoleWhat they receive
MA + RosuvastatinExperimentalPatients 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.
Receives: Drug: Megestrol Acetate; Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological response rate

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

    Measured: 12 to 16 weeks

Secondary outcomes (6)

  1. Pathological response rate

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

    Measured: 28 to 32 weeks

  2. Pathological response duration

    Pathological response duration

    Measured: up to 2 years

  3. Pathological response rate classified by different blood lipid level

    Pathological response rate classified by different blood lipid level

    Measured: up to 32 weeks

  4. Toxicity evaluation

    Toxicity evaluation according to CTCAE 5.0 version.

    Measured: up to 32 weeks

  5. Relapse rate

    Measured: Up to 2 years after the end of treatment

  6. Pregnancy rate

    Measured: Up to 2 years after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2020
  2. Study start1 Sep 2020
  3. Primary completion11 Aug 2023
  4. Study completion11 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Simon two-stage optimal design
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04491643
Sponsor's protocol ID
53211029-02
Status last verified
Aug 2025
First submitted
21 Jun 2020
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Megestrol Acetate and Rosuvastatin in people with Endometrial Carcinoma Stage I, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological response rate (time frame: 12 to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04491643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in