Weight management combined with hormonal treatment for women with endometrial atypical hyperplasia

Weight Management Plus Levonorgestrel Intrauterine System or Megestrol Acetate in Endometrial Atypical Hyperplasia: Multiple Single-arm, Prospective and Open-label Clinical Study

This study is testing if combining weight management with hormonal treatments can help obese women with endometrial atypical hyperplasia who want to keep their fertility have better treatment results and pregnancy chances.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 172 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05316493 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of weight management alongside either a levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese women diagnosed with endometrial atypical hyperplasia (EAH) who desire to preserve their fertility. The study aims to enhance treatment outcomes by addressing obesity, which is known to negatively impact response rates to fertility-sparing therapies. Participants will undergo an intensive lifestyle intervention focusing on diet, exercise, and behavioral changes, while receiving hormonal treatment. The goal is to improve complete remission rates and pregnancy outcomes in this patient population.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 45 with a BMI of 24 kg/m² or higher, diagnosed with endometrial atypical hyperplasia, and seeking fertility preservation.

Not a fit: Patients with severe medical conditions or significant liver or kidney dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes and fertility preservation for obese women with endometrial atypical hyperplasia.

How similar studies have performed: Previous studies have shown that weight management can improve treatment outcomes in similar patient populations, suggesting a promising approach.

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.

Where this trial is running

Shanghai

• Obstetrics and Gynecology Hospital of Fudan University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: XIAOJUN CHEN, PhD — Obstetrics & Gynecology Hospital of Fudan University
• Study coordinator: WEIWEI SHAN, PhD

Conditions Atypical Endometrial Hyperplasia; Fertility Issues; Overweight and Obesity