Pg. Crosignani et al., LEUPROLIDE IN A 3-MONTHLY VERSUS A MONTHLY DEPOT FORMULATION FOR THE TREATMENT OF SYMPTOMATIC ENDOMETRIOSIS - A PILOT-STUDY, Human reproduction, 11(12), 1996, pp. 2732-2735
An open-label randomized pilot study was conducted to evaluate the eff
icacy and acceptability of 6 months treatment with leuprolide in a 3-m
onthly versus a monthly i,m, depot injection for tile relief of chroni
c pelvic pain in women with endometriosis. A total of 30 women aged 18
-38 years were allocated to the 3-monthly depot arm (n = 15) or to the
monthly depot arm (n = 15) after laparoscopic diagnosis of pelvic end
ometriosis. Mean (SD) deep dyspareunia scores according to a 0-3 point
verbal rating scale decreased from 1,8 (0.9) at baseline to 1.3 (0.7)
at the end of treatment in the 3-monthly depot group and from 2.1 (1.
2) to 1.3 (0,7) in the monthly depot group, Corresponding values in no
n-menstrual pain scores fell from 2,1 (0.6) to 1.1 (0.3), and from 2.1
(0.8) to 1.2 (0.4) respectively, without statistically significant di
fferences between the groups, Serum luteinizing hormone (LH) and 17 be
ta-oestradiol concentrations were significantly suppressed at 12 and 2
4 weeks compared with baseline values, without differences between the
groups, The monthly depot caused a slightly more marked inhibition of
serum follicle stimulating hormone (FSH) levels with respect to the 3
-monthly preparation, Mean (SD) endometriosis scores at baseline and a
t 6-month follow-up laparoscopy were respectively 32.8 (25.1) and 12.2
(9.3) in the 3-monthly depot group and 29.0 (22.7) and 13.1 (15.3) in
the monthly depot group (paired t-test, P < 0.05), Mean percentage de
crease in lumbar spine bone mineral density was 5.2% in the former and
4.9% in the latter subjects, in the 3-monthly depot group, 13 women g
raded the tolerability of their treatment schedule as 'good' compared
with seven in the monthly depot group (chi(2) = 5.40, P = 0.02).