Endometrial cancer and atypical endometrial hyperplasia in obese patients
Conditions
Interventions
The group observing the effect of semaglutide combined with progestin:None
The group treated with metformin combined with progestogen:None
Sponsors
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 20-40 years old with reproductive needs; 2. Diagnosed with atypical endometrial hyperplasia (EAH) or FIGO IA stage endometrial adenocarcinoma (G1 grade) through hysteroscopy and endometrial biopsy; 3. No myometrial invasion and no extrauterine lesions suggested by imaging examinations (MRI or ultrasound); 4. Meet the obesity criteria (BMI >= 28 kg/m^2, or BMI >= 27 kg/m^2 with metabolic abnormalities); 5. Have abnormal indicators related to insulin resistance; 6. Have not received any related treatments such as hormone or chemotherapy; 7. Have basically normal liver and kidney functions and can tolerate the treatment; 8. Voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.TP53-mutated endometrial carcinoma; 2.Known hypersensitivity to semaglutide or progestin; 3.History of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); 4.History of pancreatitis; 5.Contraindications to progestin therapy; 6.Pregnant or breastfeeding women; 7.Severe dysfunction of major organs (heart, liver, or kidney) or other active malignancies; 8.Use of other weight-loss medications or participation in other clinical studies; 9.Any other conditions judged by the investigator to be unsuitable for participation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate at 3 months and within 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease recurrence rate;Time to pathological complete remission;Changes in body weight, body mass index, and waist circumference;Changes in glucose metabolism and insulin resistance parameters;Incidence of adverse events of special interest;Incidence of adverse events and serious adverse events;Changes in lipid profile;Fertility outcomes, including clinical pregnancy rate, live birth rate, and miscarriage rate;Changes in CA125 and high-sensitivity C-reactive protein; | — |
Countries
China
Contacts
Public ContactJiandong Wang
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Outcome results
None listed