Medroxyprogesterone acetate and atorvastatin for young women with early endometrial cancer and atypical hyperplasia

Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma

This study is testing if a combination of two medications can help young women with early endometrial cancer and a related condition improve their health while keeping their ability to have children.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 17 Years to 45 Years
• Sex: Female
• Sponsor: Peking University People's Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05675787 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of medroxyprogesterone acetate (MPA) combined with atorvastatin in treating young women diagnosed with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC). Participants will receive daily doses of MPA and atorvastatin for at least three months, followed by regular evaluations through hysteroscopy to assess the endometrial condition. The study aims to determine the treatment's effectiveness in reversing AEH and EEC while preserving reproductive function. Various health metrics, including blood tests and body fat assessments, will be collected to monitor participants' overall health and treatment response.

Who should consider this trial

Good fit: Ideal candidates are young women with a confirmed diagnosis of AEH or well-differentiated EEC who wish to maintain their reproductive function.

Not a fit: Patients with confirmed reproductive system cancers or those already on lipid-lowering medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a conservative management option for young women with early endometrial cancer, preserving their reproductive capabilities.

How similar studies have performed: While the combination of MPA and atorvastatin is a novel approach, similar studies have shown promise in conservative treatments for endometrial conditions.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Where this trial is running

Beijing, Beijing Municipality

• Wang Jianliu — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: WANG JIANLIU, PhD/MD

Conditions Atypical Endometrial Hyperplasia; Endometrial Carcinoma Stage I; Endometrial Carcinoma