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Clinical Trials in China / NCT06390904
Active, not recruiting Phase 2/3

GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients

NCT06390904 · tracked via the Priya Life Science China tracker
Sponsor
Xiaojun Chen
Phase
Phase 2/3
Started
2022-07-13
Last updated
2025-08-11

Condition(s) studied

Atypical Endometrial HyperplasiaProgesterone ResistanceObesity

Investigational drug(s) / intervention(s)

GnRH antagonistLetrozole 2.5mg

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)

Trial sites (2)

FacilityCityRegionStatus
Tenth People's Hospital of Tongji University Shanghai Shanghai Municipality
Obstetrics and Gynecology Hospital, Fudan University Shanghai China

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Other trials for the same condition

Official registry record

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.

View NCT06390904 on ClinicalTrials.gov ↗ ← All trials in China