Clinical trial
GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients
Active, not recruiting · Phase 2, Phase 3 · 1 countries · Registry ID NCT06390904
What this study is about
To investigate the efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) plus letrozole in obese progestin-insensitive atypical endometrial hyperplasia (EAH) patients.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
Primary outcomes
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.