Atypical Endometrial HyperplasiaPhase 2/3NCT04491682
Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
A Phase 2/3 study testing Megestrol Acetate and Rosuvastatin in people with Atypical Endometrial Hyperplasia, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Atypical Endometrial Hyperplasia
- 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
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 20 Jun 2022
- Phase
- Phase 2/3
- 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
- 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)
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- 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 statins
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- 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.
About this study
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.
Read the 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.
- Conditions
- Atypical Endometrial Hyperplasia
- Being tested
- Megestrol Acetate, Rosuvastatin
- Keywords
- megestrol acetate, rosuvastatin, atypical endometrial hyperplasia, conservative treatment
- Medical subject headings
- Endometrial Hyperplasia
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 group | Role | What they receive |
|---|---|---|
| MA + Rosuvastatin | Experimental | Patients 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, it may not be possible to 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.
Pathological response rate
From date of randomization or 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)
Pathological response rate
From date of randomization or initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 32 weeks.
Measured: 28 to 32 weeks
Pathological response duration
Pathological response duration
Measured: Up to 2 years
Pathological response rate classified by different blood lipid level
Pathological response rate classified by different blood lipid level
Measured: Up to 32 weeks
Toxicity evaluation
Toxicity evaluation according to CTCAE 5.0 version.
Measured: Up to 32 weeks
Relapse rate
Measured: up to 2 years after the therapy for each patient
Pregnancy rate
Measured: up to 2 years after the therapy for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Sep 2020
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Endometrial HyperplasiaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Chen, Obstetrics & Gynecology Hospital of Fudan University
- Investigators
- Xiaojun Chen, Principal investigator, Obstetrics and Gynecology Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491682
- Sponsor's protocol ID
- 53211029-01
- Status last verified
- Jan 2024
- First submitted
- 21 Jun 2020
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
- ClinicalTrials.gov ID
- NCT04491682
- Acronym / sponsor ID
- 53211029-01
- Conditions
- Atypical Endometrial Hyperplasia
- Keywords
- megestrol acetate, rosuvastatin, atypical endometrial hyperplasia, conservative treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MA + Rosuvastatin | Experimental | Drug: Megestrol Acetate, Drug: RosuvastatinPatients 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, it may not be possible to accept hysteroscopic evaluation every three months, then the longest duration will be 8 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megestrol AcetateAt a dosage of 160 mg/day | Drug | MA + Rosuvastatin |
| RosuvastatinAt a dosage of 10 mg/day | Drug | MA + Rosuvastatin |
Primary outcome
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.
6 secondary outcomes
Pathological response rate
Time frame: 28 to 32 weeks
Pathological response duration
Time frame: Up to 2 years
Pathological response rate classified by different blood lipid level
Time frame: Up to 32 weeks
Toxicity evaluation
Time frame: Up to 32 weeks
Relapse rate
Time frame: up to 2 years after the therapy for each patient
Pregnancy rate
Time frame: up to 2 years after the therapy for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojun Chen principal investigator
Obstetrics and Gynecology Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Megestrol Acetate and Rosuvastatin in people with Atypical Endometrial Hyperplasia, 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 9 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 29 Jan 2024. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 29 Jan 2024.