OBJECTIVE: To review the efficacy and safety of nafarelin in the treatment
of leiomyomas.
STUDY DESIGN: A literature review of published clinical trials was conducte
d. Six studies, including a total of 602 patients with leiomyomas, were rev
iewed. Patients received intranasal nafarelin, 50-400 mu g twice daily for
three to six months. Vaginal bleeding patterns, leiomyoma and uterine size,
surgical conditions and adverse effects were assessed.
RESULTS: Nafarelin consistently suppressed estrogen production, reduced lei
omyoma and uterine size, and controlled menorrhagia. The significant reduct
ion in uterine bleeding and amenorrhea resulting from administration of naf
arelin was associated with a rise in mean hemoglobin concentrations, In add
ition, nafarelin im proved hematologic parameters in women with and without
anemia. Nafarelin was well tolerated, although hot flushes were the most c
ommonly reported adverse events. Measured bone mineral density decreased si
gnificantly during treatment, although by six to nine months posttreatment,
it increased to values not significantly different from baseline. The adve
rse effects of nafarelin were generally reversible after treatment withdraw
al.
CONCLUSION: Nafarelin treatment of women with symptomatic leiomyomas effect
ively decreases uterine bleeding; improves hematologic parameters; manages
symptoms of menometrorrhagia, dysmenorrhea and pelvic discomfort; reduces u
terine and myoma size; and is well tolerated. Reduction in bone mineral den
sity occurs, but levels return to, ol near, baseline levels within six mont
hs after treatment.