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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 17
Maximum Age: 45
Healthy Volunteers: f
View:

• 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);

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Jianliu Wang, professor
wangjianliu1203@163.com
00861088324381
Backup
HE YIJIAO, PHD/MD
heyijiao2017@pku.edu.cn
18301512017
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 38
Treatments
No_intervention: control group
Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or mirena +GnRHa 3.75mg subcutaneous injection monthly);
Experimental: experimental group
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);
Related Therapeutic Areas
Sponsors
Collaborators: Beihang University, Peking University
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov