NCT05316935RecruitingPhase 2/3
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 29 Mar 2022
- Start date
- 13 Jul 2022
- Primary completion date
- 30 Mar 2028
- Lead sponsor
- Xiaojun Chen
- Diseases
- Obesity, Endometrial cancer
- NCT number
- NCT05316935
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 80
- From 13 Jul 2022 to the primary completion date, 30 Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 Diane-35, GnRHa, Letrozole or MET
- Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
Other
- Strong request for uterine removal or other conservative treatment
- Known or suspected pregnancy
- Smoker(\>15 cigarettes a day)
Who the study is looking for
- Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or well-differentiated EEC G1 without myometrial invasion
- BMI\<30kg/m2
- No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
- Using progestin, any of the following therapy, as first-line treatment:
- Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not
- Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not
- LNG-IUS inserted
- Progestin-insensitive:
- remained with stable disease after 7 months of progestin use
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tenth People's Hospital of Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Obstetrics and Gynecology Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.