During the past decade, the development of various gonadotrophin-releasing
hormone (
Gn-RH) agonists, which induce reversible hypo-oestrogenism has opened a new area in the medical management of
endometriosis. In an open, multicentre phase III study, the efficacy, tolerance and safety of the
Gn-RH agonist
leuprorelin acetate were tested. The preliminary results of 104 women treated in seven German centres are presented. Pelvic
endometriosis was diagnosed by laparoscopy and classified according to the American Fertility Society scoring system: 33% of patients had minimal, 22% mild, 28% moderate and 8% severe
endometriosis and in 9% no pathological results were obtained. The patients' mean age was 30 +/- 6 years and 66 had
infertility problems. Treatment was started within the first 3 days of the menstrual cycle and consisted of a
subcutaneous injection of
leuprorelin acetate 3.75 mg, repeated once monthly over 24 weeks. A follow-up period of 12 months after the last injection has been completed in 70 patients, including a second laparoscopy. At all visits, symptoms were evaluated, physical examinations performed, and blood samples collected for haematological screening, serum chemistry determinations and measurement of the gonadotrophins
oestradiol and
progesterone and
leuprorelin acetate. The median score at laparoscopy fell from 12 before operation to 8 after operation and 2
after treatment with
leuprorelin acetate. Of the total number of patients, 89% had improvements in their
endometriosis, 8% a deterioration and 3% no change. Patients reported improvement in the following: dysmenorrhoea 93%,
dyspareunia 62% and
pelvic pain 70%. However, all women complained of at least one of the following symptoms: hot flushes 86%, sleep disturbance 62%, sweating 61%,
headache 41%,
nausea 32% and depression 20%. Fifty-five percent of patients reported additional side effects such as vaginal dryness,
fatigue and lower
abdominal pain. After the third injection, amenorrhoea persisted in 94% of the women. Four weeks after the first
leuprorelin acetate injection median concentrations of
oestradiol fell from 45 pg/ml to 11 pg/ml,
follicle-stimulating hormone from 7 U/L to 3 U/L and luteinising
hormone from 5 U/L to 1 U/L and remained almost unchanged over the observation period. During the 6 months' treatment, laboratory parameters showed no significant deviations from normal; only total
cholesterol,
high-density lipoprotein cholesterol and
alkaline phosphatase increased. Treatment results were judged as good and satisfactory in 82% and 11% of cases, respectively. On the basis of this study, it can be concluded that
leuprorelin acetate treatment is safe, well tolerated and effective in the medical management of
endometriosis and
endometriosis-related complaints.