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New treatment option for Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I
Official title Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
ClinicalTrials.gov ID: NCT06102863
What this study is testing
What is statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);?
statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day); is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for atypical endometrial hyperplasia and endometrial carcinoma stage i.
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 Progesterone Therapeutic Regimen Plus Statins 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
- Which group you join is decided by chance.
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
- The pathological types are consistent with:
- Atypical endometrial hyperplasia;
- Patients with highly differentiated endometrioid adenocarcinoma, stage IA, and pelvic and abdominal MRI before treatment excluded deep muscle...
- There is a strong need to preserve reproductive function; Age ≤45 years old;
- Progesterone resistant patients predicted by the progesterone sensitivity prediction model (NCT05647109) established by our team in the previous...
You likely can't join if
- (1) Patients with severe internal diseases and severe impairment of liver and kidney function;
- (2) Disease progression, extrauterine metastasis (cervical invasion or distant metastasis such as pelvic cavity) during treatment;
- (3) People with therapeutic drug allergies and contraindications;
- (4) Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; Patients with breast cancer or other...
- (5) Patients with deep vein thrombosis, stroke and myocardial infarction during treatment;
- (6) Alcoholics (\> 20g/ day);
See the full eligibility criteria
- The pathological types are consistent with:
- Atypical endometrial hyperplasia;
- Patients with highly differentiated endometrioid adenocarcinoma, stage IA, and pelvic and abdominal MRI before treatment excluded deep muscle infiltration, cervical involvement, and extrauterine metastasis;
- There is a strong need to preserve reproductive function; Age ≤45 years old;
- Progesterone resistant patients predicted by the progesterone sensitivity prediction model (NCT05647109) established by our team in the previous study of endometrial cancer were prospectively assigned by chance; The...
- Informed consent and signed informed consent;
- have follow-up conditions and are willing to continue to follow the visitors in the hospital;
- Patients with normal/abnormal blood lipids who have not taken any lipid-lowering drugs;
- A. Newly treated patients: did not use any nursery therapy drugs (progesterone, GNRH-a); B. 1 course of treatment (12 weeks) the lesions persisted; C. Partial remission for 2 courses of treatment (24 weeks);
- (1) Patients with severe internal diseases and severe impairment of liver and kidney function;
- (2) Disease progression, extrauterine metastasis (cervical invasion or distant metastasis such as pelvic cavity) during treatment;
- (3) People with therapeutic drug allergies and contraindications;
- (4) Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; Patients with breast cancer or other hormone-dependent tumors that cannot use progesterone;
- (5) Patients with deep vein thrombosis, stroke and myocardial infarction during treatment;
- (6) Alcoholics (\> 20g/ day);
- (7) Smokers (\> 15 cigarettes/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.