1. Patients and treatment
The flow of the patients in the trial is reported in Figure 1. Totally 206 patients were screened, of them, 26 patients were deemed ineligible mostly because of progestin-use history or requirement of definitive surgery. Between July 21th, 2017 and June 18th, 2020, 180 patients who met all the inclusion and exclusion criteria were randomly 1:1:1 assigned to MA (n=60), LNG-IUS (n=60) or MA+LNG-IUS group (n=60) (Fig.1). One hundred and thirty-two patients and 146 patients were included in modified intention-to-treated analyses for 16-week or 32-week CR rates, respectively.
All the participants were Chinese Asian. Patient characteristics were well balanced among three treatment groups (Table S1). The median age was 33 (range 19-44) years old, and the median BMI was 25.0 (range, 16.4-47.5) kg/m2. There was no difference in age, pretreatment BMI or IR status among the three groups. Fifty-five out of 180 patients (30.6%) were obese (BMI≥28 kg/m2) and 27.8% (50/180) of patients were insulin resistant (HOMA-IR≥2.95).