3.1. Characteristics of Study Population
After randomization, the participants were classified into the safety analysis group, ITT analysis group, and PP analysis group based on the application of the investigational drug and the primary efficacy evaluation. The distribution of participants, along with the number of participants, is presented in Two participants who only received an assigned number without receiving the investigational drug were excluded from the ITT analysis. During the clinical trial, a total of 6 participants were also excluded, including participants from the treatment group. The reasons for exclusion were the following: two participants violated the selection criteria based on estradiol levels; two participants were concurrently using prohibited medications; and two participants were excluded based on the researcher’s judgment.A total of 52 participants were registered at Korea University Medical Center, with 52 participants from Inha University Hospital. The demographic and clinical history characteristics were analyzed in the ITT analysis population, which was the target for efficacy evaluation. The demographic characteristics are presented in 