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.


METHODS
Phase III, randomized, double-blind, multicenter, controlled trial.


METHODS
Twenty-four study centers in Japan.


METHODS
Two hundred seventy-one patients with endometriosis.


METHODS
Dienogest (2 mg/day, orally) or BA (900 microg/day, intranasally) for 24 weeks.


METHODS
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).


RESULTS
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.


CONCLUSIONS
DNG is as effective as intranasal BA in alleviating endometriosis, and causes less BMD loss.
Harada
Tasuku
T
Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago, Japan. tasuku@grape.med.tottori-u.ac.jp
Momoeda
Mikio
M
Taketani
Yuji
Y
Aso
Takeshi
T
Fukunaga
Masao
M
Hagino
Hiroshi
H
Terakawa
Naoki
N
D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control; D000281:Administration, Intranasal; D000284:Administration, Oral; D015519:Bone Density / Q000187:drug effects; D002064:Buserelin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004414:Dyspareunia / Q000209:etiology / Q000517:prevention & control; D004715:Endometriosis / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007564:Japan; D017116:Low Back Pain / Q000209:etiology / Q000517:prevention & control; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement; D016896:Treatment Outcome
C023635:dienogest; D009277:Nandrolone; D002064:Buserelin