End Points
blood loss, pain, Menstrual blood loss, dysmenorrhea
HEAVY MENSTRUAL BLEEDING, BLOOD LOSS, ADVERSE EVENTS, DYSMENORRHEA, SECONDARY, REMISSION
The primary efficacy end point was the change in adenomyosis-associated dysmenorrhea intensity, evaluated using the VAS, from baseline to 12 weeks of treatment. The VAS score ranged from 0 to 10, and a higher score represented greater pain intensity. The complete remission and total effective rates for dysmenorrhea were evaluated. The complete remission rate was defined as the proportion of patients who achieved a complete remission after treatment. The total efficacy rate was defined as the proportion of patients with VAS scores reduced by at least 30% from baseline to treatment completion.The first key secondary end point was the change in menstrual blood loss volume from baseline to 12 weeks in patients with heavy menstrual bleeding, including the complete remission rate and total efficacy rate for menstrual blood loss. Menstrual blood loss was analyzed with the PBAC, which is considered a valid tool with high specificity and sensitivity.Safety evaluations, including the incidence and severity of adverse events, were collected throughout the trial. Safety evaluations included various concerns after drug treatment, vital signs, endometrial biopsies, laboratory evaluations, and physical and gynecological examinations (especially changes in endometrial thickness, liver parameters, and follicle-stimulating hormone [FSH] and luteinizing hormone [LH] levels).