Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorXiaojun Chen
About this trial
To investigate the efficacy of weight management plus levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese patients with endometrial atypical hyperplasia (EAH) asking for conservative therapy.
Eligibility criteria
Qualifiers
None
Disqualifiers
Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance < 30 mL/min)
Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.
Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
Those who require hysterectomy or other methods other than conservative treatment.
Trial design
Treatments tested in this trial
- Intensive Lifestyle Intervention (ILI)
- Megestrol Acetate 160 MG Oral Tablet
- Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg
Treatment groups
172 Participants
are divided into 4 treatment groupsSponsors and collaborators
Xiaojun Chen
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov