NCT06390904Active, not recruitingPhase 2/3
GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients With Conservative Treatment
Source: ClinicalTrials.gov · Last updated 11 Aug 2025
Brief summary (registry, in English)
To investigate the efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) plus letrozole in obese progestin-insensitive atypical endometrial hyperplasia (EAH) patients.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 22 Apr 2024
- Start date
- 13 Jul 2022
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Xiaojun Chen
- Diseases
- Obesity
- NCT number
- NCT06390904
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 29
- From 13 Jul 2022 to the primary completion date, 30 Jul 2025
- 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 GnRHa or Letrozole
- 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
- BMI≥30kg/m2
- 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 | Unknown status |
| Obstetrics and Gynecology Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.