Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia

Launched by XIAOJUN CHEN · Apr 4, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of weight management combined with either a levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in women who are overweight and have been diagnosed with a condition called endometrial atypical hyperplasia (EAH). This condition is a change in the lining of the uterus that can lead to more serious issues if not treated. The study aims to find out if this combination can help manage the condition while also supporting the desire for fertility in women who want to preserve their ability to have children.

To participate, women must be between 18 and 45 years old, have a body mass index (BMI) of 24 or higher, and must have a confirmed diagnosis of EAH. They should also be willing to follow up with the hospital throughout the trial. However, there are certain health conditions that would exclude someone from participating, such as severe liver or kidney disease, other types of reproductive cancers, or a history of certain serious medical issues. Participants can expect to receive care and support throughout the trial, and they will be monitored closely to ensure their safety and well-being.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg/m2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.
• • 5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
• • 6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.
• Exclusion Criteria:
• • 1. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance \< 30 mL/min)
• • 2. Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.
• • 3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
• • 4. Those who require hysterectomy or other methods other than conservative treatment.
• • 5. Known or suspected pregnancy.
• • 6. Those who has contraindications to use progestin.
• • 7. Deep vein thrombosis, stroke, myocardial infarction.
• • 8. Severe joint lesions that prevent walking or movement.
• • 9. untreated or recurrent pelvic inflammatory disease (PID)
• • 10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
• • 11. Cervical dysplasia
• • 12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus
• • 13. allergic to the LNG-IUS components
• • 14. uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out.
• • Notes: the last 6 criteria are only applied for patients with LNG-IUS.