GnRH antagonist: Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks, and the maximum treatment courses will be 6. If the patient get CR within 6 courses, another 2 courses will be used as consolidation therapy.
Letrozole 2.5mg: 2.5mg po qd.
Study summary
To investigate the efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) plus letrozole in obese progestin-insensitive atypical endometrial hyperplasia (EAH) patients.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Complete response (CR) rate within 28 weeks of treatment — Up to 28 weeks 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.
Trial sites (2)
Facility
City
Region
Status
Tenth People's Hospital of Tongji University
Shanghai
Shanghai Municipality
Obstetrics and Gynecology Hospital, Fudan University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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