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).