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Copenhagen,
Denmark
19 - 22 June 2005
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Letrozole
in endometriosis: efficacy and side effects
LH Abbamonte, S Ferrero, P Anserini, V Remorgida,
N Ragni
San Martino Hospital and University of
Genoa
Department of Obstetrics and Gynaecology
Genoa, Italy
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Introduction
Aromatase inhibitors have recently been proposed
for the treatment of endometriosis in women of reproductive
age. This preliminary study evaluates the effectiveness
and the side effects of letrozole use in premenopausal
women with endometriosis.
Materials and methods
This pilot study enrolled 12 women with endometriosis
related pain that was refractory to previous treatment
or recurred after such treatment. Inclusion criteria
for the study were as follows: (1) reproductive
age women with regular menstrual cycle (age range,
29–37 years); (2) previous laparoscopy documenting
stage IV endometriosis according to the revised
American Fertility Society classification; (3) dysmenorrhea
and/or chronic pelvic pain that persisted or recurred
after one or more previous treatments employing
surgery and/or GnRH agonist.
Study exclusion criteria included undiagnosed vaginal
bleeding, ovarian cysts=2 cm, treatment in the past
3 months with hormones, current osteopenia and smoking.
The treatment protocol included the oral administration
of letrozole 2.5mg (Femara®, Novartis Farma,
Varese, Italy), desogestrel-only contraceptive pill
(Cerazette®, Organon, Rome, Italy), elemental
calcium 1000mg and vitamin D 880 IU (Calcit Vitamina
D3®, Procter & Gamble, Rome, Italy) daily
for 6 months.
During treatment patients underwent monthly transvaginal
ultrasound in order to monitor for ovarian hyperstimulation
as a side effect of aromatase inhibitor therapy;
in addition, monthly blood examinations (complete
blood count, coagulation profile and hepatic enzymes)
were performed. Before starting the treatment and
monthly during the treatment, all the patients completed
a pain scoring questionnaire, evaluating the presence
and intensity (on a 100mm visual analogue scale)
of dysmenorrhea, deep dyspareunia and chronic pelvic
pain.
Patients kept a diary for all side effects of the
treatment. The Wilcoxon signed ranks test was used
to compare the differences in pain intensity before
and after treatment.
Results
Before the treatment, all patients reported dysmenorrhea
(pain intensity, mean±SD, 8.7±1.9),
66.7% of sexually active women (n=9) had deep dyspareunia
(pain intensity, 6.5±2.9) and 58.3% of the
subjects had chronic pelvic pain (pain intensity,
5.7±2.4). None of the patients included in
the study completed the 6 months treatment, because
all the subjects developed functional ovarian cysts.
The median length of treatment was 84 days (range
56–112). The mean (±SD) largest diameter
of the functional ovarian cysts was 5.0±1.3
cm (range 3.4–8.1 cm), eight (66.7%) patients
developed more
than one ovarian cyst. At the cessation of treatment,
the patients reported significantly lower intensities
of dysmenorrhea (mean±SD, 0.8±0.7;
p=0.028) and deep dyspareunia (0.5±0.4; p=0.28)
than before treatment; no significant difference
was observed in chronic pelvic pain intensity (3.2±2.5;
p=0.173).
The following side effects were observed during
treatment: vaginal bleeding (n=5), nausea (n=3),
weight gain (n=2), tiredness (n=2), peripheral edema
(n=1) and itching (n=1). No significant change in
blood examinations was observed during treatment.
Conclusions
Although letrozole is effective in the treatment
of pain due to endometriosis, the association with
desogestrel-only contraceptive pill does not inhibit
ovarian cyst formation.
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