Atypical Endometrial HyperplasiaPhase 2NCT05675787
Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
A Phase 2 study testing Medroxyprogesterone acetate + Atorvastatin in people with Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I, run by Peking University People's Hospital at 1 site in China.
Trial summary
To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women only
- Conditions the study is for
- Atypical Endometrial Hyperplasia, Endometrial Carcinoma Stage I
- What is being tested?
- Medroxyprogesterone acetate + Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2023to 31 Oct 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 17 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;
- 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
Who cannot join
- Hypersensitivity or contradiction for using MPA or atorvastatin
- Pregnancy or potential pregnancy
- Confirmed diagnosis of any cancer in reproductive system
- Already diagnosed with hyperlipidemia and using lipid-lowering drugs
- Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
Show all 10Show fewer
- 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, 1 recruiting
- Recruiting
Wang Jianliu
Beijing, Beijing Municipality, 100044
WANG JIANLIU, PHD/MD, +861088324383, wangjianliu1203@163.com
About this study
Official title: Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.
Read the detailed description
After diagnosed of AEH or EEC by hysteroscopy, patients meet the study criteria will be enrolled. The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue was detected by Raman scattering instrument. And Age, height, weight, waistline, blood pressure, basic history of infertility and family cancer will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), blood lipids, sex hormone levels, anti-müllerian hormone (AMH) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 770.
Patients will receive MPA (Medroxyprogesterone acetate) 250-500 mg by mouth daily plus atorvastatin 20mg by mouth daily for at least 3 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. Patients with PD will be recommended for hysterectomy.
For patients remained SD after 9 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given. Three months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for at least 1 year.
- Being tested
- Medroxyprogesterone acetate + Atorvastatin
- Keywords
- Endometrial Carcinoma, Atypical Endometrial Hyperplasia
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medroxyprogesterone acetate + AtorvastatinDrug
MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | MPA + Atorvastatin Receives: Drug: Medroxyprogesterone acetate + Atorvastatin |
| Control groups | No intervention | MPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological cumulative complete response rate;
3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,
Measured: assessed up to 4 months
Secondary outcomes (7)
Pathological cumulative complete response rate;
From 6 to 8 months; From date of initial therapy until the date of CR or date of hysterectomy,
Measured: assessed up to 8 months
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion
Measured: assessed up to 4 months
Overall complete response rate
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 2 years;
Relapse rate
Relapse rate
Measured: up to 15 months after the end of treatment
Pregnancy rate
Pregnancy rate
Measured: up to 15 months after the end of treatment
Toxic Side Effect
Toxicity evaluation according to CTCAE 5.0 version.
Measured: up to 3 months 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.
- First posted9 Jan 2023
- Study start6 Jan 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
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 Peking University People's HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study: Control group and Experimental group;
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jianliu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675787
- Sponsor's protocol ID
- 2022PHB416
- Status last verified
- Jul 2024
- First submitted
- 29 Dec 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT05675787
- Acronym / sponsor ID
- 2022PHB416
- Keywords
- Endometrial Carcinoma, Atypical Endometrial Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 Jan 2023 (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 explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.
Detailed description
After diagnosed of AEH or EEC by hysteroscopy, patients meet the study criteria will be enrolled. The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue was detected by Raman scattering instrument. And Age, height, weight, waistline, blood pressure, basic history of infertility and family cancer will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), blood lipids, sex hormone levels, anti-müllerian hormone (AMH) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 770.
Patients will receive MPA (Medroxyprogesterone acetate) 250-500 mg by mouth daily plus atorvastatin 20mg by mouth daily for at least 3 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. Patients with PD will be recommended for hysterectomy.
For patients remained SD after 9 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given. Three months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for at least 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study: Control group and Experimental group;
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Medroxyprogesterone acetate + AtorvastatinMPA + Atorvastatin |
| Control groups | No intervention | –MPA |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;
- 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
Key exclusion criteria (10 listed)
- Hypersensitivity or contradiction for using MPA or atorvastatin
- Pregnancy or potential pregnancy
- Confirmed diagnosis of any cancer in reproductive system
- Already diagnosed with hyperlipidemia and using lipid-lowering drugs
- Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
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 |
|---|---|---|
| Medroxyprogesterone acetate + AtorvastatinMPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth, | Drug | Experimental group |
Primary outcome
Pathological cumulative complete response rate;
Time frame: assessed up to 4 months
3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,
7 secondary outcomes
Pathological cumulative complete response rate;
Time frame: assessed up to 8 months
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue
Time frame: assessed up to 4 months
Overall complete response rate
Time frame: up to 2 years
Pathological response rate classified by different blood lipid level
Time frame: up to 2 years;
Relapse rate
Time frame: up to 15 months after the end of treatment
Pregnancy rate
Time frame: up to 15 months after the end of treatment
Toxic Side Effect
Time frame: up to 3 months after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medroxyprogesterone acetate + Atorvastatin in people with Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I, run by Peking University People's Hospital 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WANG JIANLIU, PhD/MD (+861088324383, wangjianliu1203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological cumulative complete response rate; (time frame: assessed up to 4 months). 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 11 Jul 2024.