Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia

NCT06102863 | Recruiting Phase 2 DMC

• 1 other identifier: 20231022
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I

Outcome Measures

Primary Outcomes (1)

• Pathological cumulative complete response rate;

  From 6 to 7 months: From date of initial therapy until the date of CR.

  assessed up to 7 months

Secondary Outcomes (6)

• Pathological cumulative complete response rate;

  assessed up to 4 months

• The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue

  assessed up to 7 months

• Overall complete response rate

  up to 2 years

• Relapse rate

  up to 15 months after the end of treatment.

• Toxic Side Effect

  up to 3 months after the end of treatment.

Study Arms (2)

control group

NO INTERVENTION

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or mirena +GnRHa 3.75mg subcutaneous injection monthly);

experimental group

EXPERIMENTAL

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);

Drug: statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);

Interventions

statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day); DRUG

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);

experimental group

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 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 randomized; The predicted progesterone sensitive patients were prospectively observed;
• 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);

You may not qualify 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 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)

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beihang University: collaborator
• Peking University: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Jianliu Wang, professor

  Peking University /Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Jianliu Wang, professor

CONTACT

00861088324381; wangjianliu1203@163.com

HE YIJIAO, PHD/MD

CONTACT

18301512017; heyijiao2017@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretary of the Party Committee,Vice president

Model Details: Patients with endometrial cancer who met the inclusion criteria were randomly divided into the control group and the experimental group in a 1:1 ratio according to the random numbers generated in advance (no preset position, no specific object).

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: April 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)