Recruiting PHASE2 Atypical Endometrial Hyperplasia

New treatment option for Atypical Endometrial Hyperplasia

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

ClinicalTrials.gov ID: NCT05675787

What this study is testing

What is Medroxyprogesterone acetate + Atorvastatin?

Medroxyprogesterone acetate + Atorvastatin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atypical endometrial hyperplasia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 17 to 45, women only

You may be able to join if

  • Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can 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...
  • 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
What rules you out
  • 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)

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, Beijing Municipality, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 17 years to 45 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.