Clinical trial

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

Active, not recruiting · Phase 2, Phase 3 · 1 countries · Registry ID NCT06390904

Active, not recruitingPhase 2, Phase 3Interventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years
SexFemale
Healthy volunteersNot accepted
ConditionAtypical Endometrial Hyperplasia, Progesterone Resistance, Obesity

Full registry 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)

Treatments and study arms

GnRH antagonist

Drug

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

Drug

2.5mg po qd.

Primary outcomes

Complete response (CR) rate within 28 weeks of treatmentUp 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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

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