Very low dose danazol for relief of endometriosis-associated pelvic pain: a pilot study.
OBJECTIVE
To evaluate the efficacy and safety of very low dose danazol in improving pelvic pain in women with endometriosis, the benefit of preceding the treatment by a short course of a GnRH agonist, symptoms recurrence after drug withdrawal, and variations in menstrual pattern.


METHODS
Open-label, randomized study.


METHODS
University hospital endometriosis center.


METHODS
Forty-two women with moderate or severe pelvic pain and laparoscopically diagnosed endometriosis.


METHODS
Treatment with oral danazol, 50 mg/d, for 9 months (group I, n = 21) or leuprolide depot for 3 months followed by oral danazol, 50 mg/d, for 6 months (group II, n = 21), and a 6-month follow-up.


METHODS
Variations in severity of symptoms during treatment and at the end of follow-up as shown by a linear analog scale and a verbal rating scale; menstrual blood loss as assessed by a pictorial chart.


RESULTS
Four patients withdrew from the study, one in each group at the fifth month of treatment (for persistent pain) and one in each group during follow-up (they requested additional therapy); one woman in group I was lost to follow-up. Significant improvements were obtained in dysmenorrhea, deep dyspareunia, and nonmenstrual pain in both treatment schedules without differences between the groups. Also menstrual blood loss was significantly reduced in both groups. A temporary fall in high and rise in low density lipoprotein cholesterol was observed in the study population. At the end of follow-up symptoms recurred without significant differences in median pain scores with respect to baseline.


CONCLUSIONS
Very low dose danazol may be an alternative for temporary relief of endometriosis-associated pain. Ovulation is not always inhibited and barrier contraception is needed. Side effects occur but are rarely severe. Further data are required to evaluate the influence of long-term administration on the lipid profile.
Vercellini
P
P
Clinica Ostetrica e Ginecologica L. Mangiagalli, University of Milan, Italy.
Trespidi
L
L
Panazza
S
S
Bramante
T
T
Mauro
F
F
Crosignani
P G
PG
D000293:Adolescent; D000328:Adult; D003613:Danazol / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004715:Endometriosis / Q000150:complications* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D010147:Pain Measurement; D010166:Palliative Care; D017699:Pelvic Pain / Q000188:drug therapy* / Q000209:etiology*
D003613:Danazol