Loading
Progesterone Resistance / Diane-35 / Atypical Endometrial Hyperplasia · Phase 2/3 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospectively registered, actively recruiting Phase 2/3 trial comparing GnRHa plus letrozole versus Diane-35 plus metformin in non-obese patients with progestin-insensitive endometrial cancer or atypical hyperplasia seeking conservative treatment. No results have been posted to the registry; the record describes only the planned protocol and primary endpoint (complete response rate at 28 weeks).
Phase 2/3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Endometrial Neoplasms, Atypical Endometrial Hyperplasia, Progesterone Resistance; Female; age from 18 Years; to 45 Years. Intervention: Non-obese EEC group (G); Non-obese EEC group (D); Non-obese EAH group (G); Non-obese EAH group (D). Compared with: Diane-35 plus metformin. n = 80. 2 sites: China.
This is a prospectively registered, actively recruiting Phase 2/3 trial comparing GnRHa plus letrozole versus Diane-35 plus metformin in non-obese patients with progestin-insensitive endometrial cancer or atypical hyperplasia seeking conservative treatment. No results have been posted to the registry; the record describes only the planned protocol and primary endpoint (complete response rate at 28 weeks).
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial addresses an underexplored population (non-obese progestin-insensitive endometrial disease) and may inform treatment of hormonally resistant disease. Results are not yet available and cannot inform current practice.
This is an active registry record for a Phase 2/3 interventional trial with no posted results; it describes planned enrollment and methodology only.
As stated by the source record.
Quoted from the source exactly as published.
This trial addresses an underexplored population (non-obese progestin-insensitive endometrial disease) and may inform treatment of hormonally resistant disease. Results are not yet available and cannot inform current practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05316935). This is a study registration, not published results. Lead sponsor: Xiaojun Chen. Recruitment status: RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: Endometrial Neoplasms, Atypical Endometrial Hyperplasia, Progesterone Resistance. Interventions: DRUG: GnRHa; DRUG: Letrozole 2.5mg; DRUG: Diane-35; DRUG: MET. Primary outcome measures: Complete response rates within 28 weeks of treatment , From date of randomization until the date of CR, assessed up to 28 weeks. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.