Using GnRHa and Letrozole for Obese Patients with Atypical Endometrial Hyperplasia

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients With Conservative Treatment

This study is testing if a combination of two medications can help obese patients with atypical endometrial hyperplasia who haven't had success with other treatments.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Fudan University (other)
• Locations: 2 sites (Shanghai, Shanghai and 1 other locations)
• Trial ID: NCT06390904 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Gonadotropin-releasing Hormone Agonist (GnRHa) combined with letrozole in treating obese patients who are resistant to progestin therapy for atypical endometrial hyperplasia (EAH). The study aims to enroll patients diagnosed with EAH who have a body mass index (BMI) of 30 kg/m² or higher and have not responded to previous progestin treatments. The primary goal is to assess the cumulative complete response rate after 28 weeks of treatment, while secondary endpoints include monitoring adverse events and the duration of response. This single-centered prospective pilot study seeks to provide new evidence for improving conservative treatment options for these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are obese women with a confirmed diagnosis of atypical endometrial hyperplasia who have not responded to progestin therapy.

Not a fit: Patients with severe medical conditions, liver or kidney impairment, or those diagnosed with endometrial cancer are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for obese patients with progestin-insensitive atypical endometrial hyperplasia, potentially preserving their fertility.

How similar studies have performed: This approach is novel and has not been previously tested in similar studies, making it a potentially groundbreaking investigation.

Eligibility criteria

Inclusion Criteria:

* Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH
* BMI≥30kg/m2
* Using progestin, any of the following therapy, as first-line treatment:

  1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not
  2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not
  3. LNG-IUS inserted
* Progestin-insensitive:

  1. remained with stable disease after 7 months of progestin use
  2. did not achieve CR after 10 months of progestin use
* Have a desire for remaining reproductive function or uterus
* Good compliance with adjunctive treatment and follow-up

Exclusion Criteria:

* Combined with severe medical disease or severely impaired liver and kidney function
* Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis
* Patients with other types of endometrial cancer or other malignant tumors of the reproductive system
* Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with GnRHa or Letrozole
* Strong request for uterine removal or other conservative treatment
* Known or suspected pregnancy
* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
* Smoker(\>15 cigarettes a day)

Where this trial is running

Shanghai, Shanghai and 1 other locations

• Tenth People's Hospital of Tongji University — Shanghai, Shanghai, China (RECRUITING)
• Obstetrics and Gynecology Hospital, Fudan University — Shanghai, China (RECRUITING)

Conditions: Atypical Endometrial Hyperplasia, Progesterone Resistance, Obesity