Obesity Clinical Trial
Official title:
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients With Conservative Treatment
Verified date | April 2024 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) plus letrozole in obese progestin-insensitive atypical endometrial hyperplasia (EAH) patients.
Status | Recruiting |
Enrollment | 29 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
China | Obstetrics and Gynecology Hospital, Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xiaojun Chen |
China,
Zhou S, Xu Z, Yang B, Guan J, Shan W, Shi Y, Chen X. Characteristics of progestin-insensitive early stage endometrial cancer and atypical hyperplasia patients receiving second-line fertility-sparing treatment. J Gynecol Oncol. 2021 Jul;32(4):e57. doi: 10.3802/jgo.2021.32.e57. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete response (CR) rate within 28 weeks of treatment | The cumulative 28-week CR rate will be calculated. Patients will be evaluated with an hysteroscopy every 12 to 16 weeks. The response to progestin treatment was assessed histologically using specimens obtained during each hysteroscopic evaluation. CR was defined as the absence of hyperplasia or carcinoma. | Up to 28 weeks | |
Secondary | Adverse events | Adverse effects were recorded during the entire treatment period, including weight gain, thrombosis, lactic acidosis, abnormal liver and renal function, and other toxicities or complaints. | During the treatment period, an average of 28 weeks | |
Secondary | Time to achieve CR | The median CR time will be calculated. | During the treatment period, an average of 28 weeks | |
Secondary | Relapse rate | Relapse will be defined as endometrial hyperplasia or endometrial cancer recurred after patients achieve CR. | Average of 2 years after the completion of the treatment | |
Secondary | Rate of fertility outcomes | Among patients prepared to get pregnant, fertility outcomes will be recorded. | Average of 2 years after the completion of the treatment |
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