Abstract
Background
The purpose of this study was to investigate the effectiveness of a combination of ethinylestradiol (EE) and 0.02 mg/drospirenone (DRSP) 3 mg in Japanese women with dysmenorrhea and in particular to determine whether or not the presence of specific coexisting organic diseases (eg, endometriosis, uterine fibroids, uterine adenomyosis) has an impact on treatment.
Methods and results
Four hundred and ten patients with dysmenorrhea aged 20 years or older (315 without coexisting organic disease, 28 with endometriosis, 37 with uterine fibroids, and 46 with uterine adenomyosis [some patients had multiple coexisting organic diseases]) were enrolled and treated with EE/DRSP in either a 16-week comparator study or a 52-week long-term safety study. Evaluations included changes in total dysmenorrhea score, visual analog scale for dysmenorrhea, severity of symptoms, hormone levels, endometrial thickness, and safety outcomes. In both studies, the total dysmenorrhea score was significantly (P<0.001) decreased from baseline during treatment with EE/DRSP. Time-dependent changes in visual analog score for dysmenorrhea and alleviation of symptoms, such as lower abdominal pain, low back pain (lumbago), headache, and nausea/vomiting, were similar in all patient groups with and without any specific coexisting organic diseases. These improvements with EE/DRSP were observed for both short-term (16 weeks) and long-term (52 weeks) use. These effects were associated with suppressed increases in serum estradiol and progesterone levels and decreased endometrial thickness. The safety profile of EE/DRSP was similar in all patients, irrespective of the presence of coexisting organic diseases.
Conclusion
EE/DRSP may be prescribed for patients with dysmenorrhea irrespective of the presence of any specific coexisting organic diseases.
Acknowledgments
The authors would like to thank the following doctors for participation in the studies: Shoko Koga (Koga Clinic), Kiyoko Iesaka (Iesaka Clinic), Kazunori Kinoshita (Seijo Kinoshita Hospital), Seiko Iizuka (Kosugi Clinic), Ruriko Tsushima (Women’s Wellness Ginza Clinic), Yuta Murakami (Ikebukuro Clinic), Yukari Utsugisawa (Women’s Clinic Luna), Kazuhisa Ideta (Chayamachi Ladies Clinic), Masahide Shiotani (Hanabusa Women’s Clinic), Chisato Kiuchi (Kiuchi Ladies Clinic), Hideki Hanashi and Masataka Karube (NS Clinic), Masayoshi Ishihara (Ishihara OB and GYN), Fumiyasu Nagaike (Nagaike Clinic), Chieko Kakuta (Kakuta Chieko Ladies Clinic), Katsumi Yazaki (Yazaki Clinic), Masuo Yoshioka (Suzuran Clinic), Masao Takane (Takane Clinic), Miyako Ito and Kanako Hanaoka (Ito Medical Clinic), Takuya Irie (C:z Ladies Clinic), Ken Yoshikawa (Kichijyouji Lady’s Clinic), Motoyasu Furuya (Machida Higashiguchi Clinic), Hiroko Mouri (Rinkan Clinic), Takeo Kanou (Kano’s Clinic for Women), Tadashi Iida (Iida Ladies Clinic), Sakie Niwa (Sakie Ladies Clinic), Kazume Kawabata (Kawabata Women’s Clinic), and Takeshi Yoshimura (Yoshimura Ladies Clinic). The authors would also like to thank Noboru Fujomoto (formerly Bayer Yakuhin, Ltd) for his critical review of the manuscript. Clare Wheatcroft, of inScience Communications, Springer Healthcare, provided editorial support on behalf of Bayer HealthCare Pharmaceuticals.
Author contributions
YS was involved in the initial conception and design of this project. MM advised on preparation and revision of the protocol and data handling. HM and YT contributed to the design of the studies and provided advice on data handling. MH and MM contributed toward interpretation of reanalyzed data and drafting the manuscript. All authors provided critical review of the manuscript and confirm that they have read and approved the final version to be published.
Disclosure
MH and YS are employees of Bayer Yakuhin, Ltd. MM, HM, and YT received a medical advisory fee from Bayer Yakuhin, Ltd when the two studies were planned and conducted. The two studies were funded by Bayer Yakuhin, Ltd, Osaka, Japan.