Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double-blind, multicenter, controlled trial

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 wi...

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Bibliographic Details
Published in:	Fertility and sterility 2009-03, Vol.91 (3), p.675-681
Main Authors:	Harada, Tasuku, M.D, Momoeda, Mikio, M.D, Taketani, Yuji, M.D, Aso, Takeshi, M.D, Fukunaga, Masao, M.D, Hagino, Hiroshi, M.D, Terakawa, Naoki, M.D
Format:	Article
Language:	eng
Subjects:	Abdominal Pain - etiology Abdominal Pain - prevention & control Administration, Intranasal Administration, Oral Biological and medical sciences Bone Density - drug effects bone mineral density Buserelin - administration & dosage Buserelin - adverse effects buserelin acetate Dienogest Double-Blind Method Dyspareunia - etiology Dyspareunia - prevention & control endometriosis Endometriosis - complications Endometriosis - drug therapy Female Female genital diseases Gynecology. Andrology. Obstetrics Humans Internal Medicine Investigative techniques, diagnostic techniques (general aspects) Japan Low Back Pain - etiology Low Back Pain - prevention & control Medical sciences Nandrolone - administration & dosage Nandrolone - adverse effects Nandrolone - analogs & derivatives Non tumoral diseases Obstetrics and Gynecology Osteoarticular system. Muscles Pain - etiology Pain - prevention & control Pain Measurement progestin Radiodiagnosis. Nmr imagery. Nmr spectrometry Treatment Outcome
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Summary:	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.
ISSN:	0015-0282 1556-5653