NCT06102863 Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
| NCT ID | NCT06102863 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2023-04-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * The pathological types are consistent with: 1. Atypical endometrial hyperplasia; 2. Patients with highly differentiated endometrioid adenocarcinoma, stage IA, and pelvic and abdominal MRI before treatment excluded deep muscle infiltration, cervical involvement, and extrauterine metastasis; 3. There is a strong need to preserve reproductive function; Age ≤45 years old; 4. 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; 5. Informed consent and signed informed consent; 6. have follow-up conditions and are willing to continue to follow the visitors in the hospital; 7. Patients with normal/abnormal blood lipids who have not taken any lipid-lowering drugs; 8. 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); Exclusion Criteria: * (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)
Contact & Investigator
Jianliu Wang, professor
STUDY DIRECTOR
Peking University /Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06102863 clinical trial?
This trial is open to female participants only, aged 17 Years or older, up to 45 Years, studying Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06102863 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06102863 currently recruiting?
Yes, NCT06102863 is actively recruiting participants. Contact the research team at wangjianliu1203@163.com for enrollment information.
Where is the NCT06102863 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06102863 clinical trial?
NCT06102863 is sponsored by Peking University People's Hospital. The principal investigator is Jianliu Wang, professor at Peking University /Peking University People's Hospital. The trial plans to enroll 38 participants.