Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
NCT ID: NCT05675787
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
82 participants
INTERVENTIONAL
2023-01-06
2025-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
MPA + Atorvastatin
Medroxyprogesterone acetate + Atorvastatin
MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,
Control groups
MPA
No interventions assigned to this group
Interventions
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Medroxyprogesterone acetate + Atorvastatin
MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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)
17 Years
45 Years
FEMALE
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Wang Jianliu
Professor, Doctoral supervisor, Chief physician, Vice President
Locations
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Wang Jianliu
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022PHB416
Identifier Type: -
Identifier Source: org_study_id
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