A multicenter, randomized, placebo-controlled, double-blind, comparative study of dienogest at 1 mg/day in patients with primary and secondary dysmenorrhea.

OBJECTIVE

To evaluate the efficacy and safety of dienogest (DNG), a progestational 19-norsteroid, in patients with primary and secondary dysmenorrhea.

DESIGN

Phase III, randomized, double-blind, multicenter, placebo-controlled study.

SETTING

Clinical study sites in Japan.

PATIENT(S): Ninety-four women with dysmenorrhea.

INTERVENTION(S): Random assignment to receive DNG (1 mg/day, orally) or placebo for 12 weeks; patients treated for anemia before randomization in cases of complicated anemia.

MAIN OUTCOME MEASURE(S): Change in the dysmenorrhea score from baseline to week 12 of treatment with visual analog scale used for pain assessment.

RESULT(S): The DNG group was superior to the placebo group in terms of the change from baseline in the dysmenorrhea score at week 12 of treatment in patients with dysmenorrhea. In both primary and secondary dysmenorrhea, the DNG group was superior to the placebo group for each diagnostic category. The mean serum estradiol concentrations were similar between the DNG and the placebo groups. Although the incidence of irregular uterine bleeding was higher in the DNG group, there were no severe or serious events. Most events of genital bleeding were spotting or breakthrough bleeding, suggesting DNG was well tolerated.

CONCLUSION(S): In both primary and secondary dysmenorrhea, DNG at 1 mg/day relieved pain and was well tolerated.

CLINICAL TRIAL REGISTRATION NUMBER

JapicCTI-173547(en).