Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double-blind, multicenter, controlled trial
Received 4 December 2007; received in revised form 31 December 2007; accepted 31 December 2007. published online 23 July 2008.
Objective
To compare the efficacy and safety of dienogest (DNG) with intranasal buserelin acetate (BA) in patients with endometriosis.
Design
Phase III, randomized, double-blind, multicenter, controlled trial.
Setting
Twenty-four study centers in Japan.
Patient(s)
Two hundred seventy-one patients with endometriosis.
Intervention(s)
Dienogest (2 mg/day, orally) or BA (900 μg/day, intranasally) for 24 weeks.
Main Outcome Measure(s)
The pre- to posttreatment changes in the scores of five subjective symptoms during nonmenstruation (lower abdominal pain, lumbago, defecation pain, dyspareunia, and pain on internal examination) and two objective findings (induration in the pouch of Douglas and limited uterine mobility).
Result(s)
Dienogest reduced the scores of all symptoms and findings at the end of treatment, and the mean changes in the scores of all symptoms and findings except induration in the pouch of Douglas were comparable to those obtained with BA. Compared with BA, DNG was associated with irregular genital bleeding more frequently and with fewer hot flushes. The reduction in bone mineral density (BMD) during DNG treatment was significantly lower than that during BA treatment.
Conclusion(s)
DNG is as effective as intranasal BA in alleviating endometriosis, and causes less BMD loss.
aDepartment of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago, Japan
bDepartment of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan
cDepartment of Comprehensive Reproductive Medicine, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan
dDepartment of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Japan
eRehabilitation Division, Tottori University School of Medicine, Yonago, Japan
Reprint requests: Tasuku Harada, M.D., Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago 683-8504, Japan (FAX: +81-859-38-6649).
Dienogest and intranasal buserelin acetate were supplied by Mochida Pharmaceutical Co., Ltd, Tokyo, Japan.
This study was sponsored by Mochida Pharmaceutical Co., Ltd.
Tasuku Harada, Mikio Momoeda, Yuji Taketani, Takeshi Aso, Masao Fukunaga, Hiroshi Hagino and Naoki Terakawa have received consulting fees from Mochida Pharmaceutical Co., LTD.
ABSTRACT