Use of nafarelin versus placebo after reductive laparoscopic surgery for endometriosis.
OBJECTIVE
To evaluate the efficacy of the GnRH agonist (GnRH-a) nafarelin compared with placebo administered for 6 months after reductive laparoscopic surgery for symptomatic endometriosis.


METHODS
Randomized, prospective, placebo-controlled, multicenter clinical trial.


METHODS
Thirteen clinics including private practice and university centers.


METHODS
One hundred nine women aged 18-47 with laparoscopically proven endometriosis and pelvic pain who had undergone reductive laparoscopic surgery for endometriosis.


METHODS
Patients were randomized to receive either the GnRH-a nafarelin (200 micrograms twice daily) or placebo for 6 months.


METHODS
Time to initiation of alternative treatment (the length of time from beginning study medication to receiving alternative therapy or to deeming that the study drug was ineffective) and patient-reported and physician-assessed pelvic pain scores.


RESULTS
The median time to initiation of alternative treatment was > 24 months in the nafarelin group versus 11.7 months in the placebo group. Fifteen (31%) of 49 nafarelin-treated patients required alternative therapy, compared with 25 (57%) of 44 placebo-treated patients. The patients' pelvic pain scores dropped significantly in the nafarelin and placebo groups after 6 months of treatment. Physician summary ratings showed significant improvement in the nafarelin group and no significant changes in the placebo group after 6 months of treatment.


CONCLUSIONS
Compared with placebo, nafarelin administered after reductive laparoscopic surgery for endometriosis significantly delays the return of endometriosis symptoms requiring further treatment.
Hornstein
M D
MD
Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts 02115, USA.
Hemmings
R
R
Yuzpe
A A
AA
Heinrichs
W L
WL
D000293:Adolescent; D000328:Adult; D003131:Combined Modality Therapy; D004715:Endometriosis / Q000188:drug therapy / Q000601:surgery*; D005260:Female; D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D010535:Laparoscopy; D008875:Middle Aged; D017274:Nafarelin / Q000627:therapeutic use*; D010919:Placebos; D011446:Prospective Studies
D006728:Hormones; D010919:Placebos; D017274:Nafarelin