Momoeda M, et al. – The goal of the study described in this paper was to evaluate the safety and effectiveness of a flexible extended regimen of ethinylestradiol/drospirenone (flexible regimen) in Japanese women with dysmenorrhea. In Japanese women with dysmenorrhea, a flexible extended regimen of ethinylestradiol/drospirenone reduced the number of days with dysmenorrheic pain versus the traditional 28d regimen.

Methods

• For this research, they designed a multicenter, open–label study.
• This study was performed in Japanese women with dysmenorrhea who, after a baseline observational phase, were randomized to receive ethinylestradiol 20 μg/drospirenone 3 mg in a flexible regimen (one tablet each day for 24–120 days followed by a 4–day tablet–free interval) or in the standard 28d regimen (one tablet each day for 24 days, followed by 4 days of placebo tablets for six cycles).
• The primary endpoint was the number of days with dysmenorrhea of at least mild intensity over a 140–day assessment period.
• In this study, dysmenorrhea scores, bleeding patterns, and other pain–related parameters were also assessed.

Results

• A total of 216 women (mean age 29.7 years) were randomized to the flexible regimen (n=108) or 28d regimen (n=108) and 212 were incorporated into the full analysis sets (flexible regimen, n=105; 28d regimen, n=107).
• Women in the flexible–regimen group reported a mean of 3.4 fewer days with dysmenorrheic pain than women in the 28d–regimen group, with similar decreases in disease severity reported in both treatment groups.
• As indicated by the investigators, 64.8% and 59.4% of women in the flexible–regimen and 28d–regimen treatment groups had “very much improved” or “much improved” disease, while 54.3% and 50.9% of patients reported being “very much satisfied” or “much satisfied” with their treatment, respectively.