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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age17-45
SponsorPeking University People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

(1) Patients with severe internal diseases and severe impairment of liver and kidney function;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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);

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: control groupNo intervention 0 interventions
Group B: experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological cumulative complete response rate;

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

Time frame
assessed up to 7 months

Secondary outcomes

1

Pathological cumulative complete response rate;

From 3 to 4 months; From date of initial therapy until the date of CR.

Time frame
assessed up to 4 months
2

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

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

Time frame
assessed up to 7 months
3

Overall complete response rate

Pathological response duration

Time frame
up to 2 years
4

Relapse rate

Relapse rate

Time frame
up to 15 months after the end of treatment.

Other outcomes

Sponsors and contacts

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Peking University People's Hospital

Lead sponsor

Beihang University

Collaborator

Peking University

Collaborator