Clinical Experience with Leuprorelin Acetate in the Treatment of Endometriosis

Kim, Sung Hoon; Kwon, Yong Soon; Oh, Young Mi; Lee, Bang Hyun; Chae, Hee Dong; Kim, Chung Hoon; Kang, Byung Moon; Nam, Joo Hyun

Abstract

OBJECTIVE
To evaluate the clinical efficacy and safety of Lorelin(R), a depot form of leuprorelin acetate made in Korea, in the treatment of endometriosis.
MATERIALS AND METHODS
Twenty patients with surgically proven endometriosis were recruited and followed during about 21 weeks of treatment. Lorelin(R) 3.75 mg was injected every 4 weeks after the first injection following initial operation and a total of six doses were injected to a patient. Symptom severity score, chemical battery, lipid battery, and serum levels of follicule stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), and CA-l25 were assayed before Lorelin(R) treatment, after 3 doses, and after 6 doses. Statistical analysis was performed utilizing repeated analysis of variance (ANOVA) and results with P-value less than 0.05 were considered significant.
RESULTS
The age range at initial operation was 25 to 48 and the mean age was 36.5+/-6.1 (mean+/-SD) years. Symptom severity score and serum levels of LH, FSH, E2, and CA-125 were significantly lower after 3 and 6 doses of Lorelin(R) than before treatment. Transient elevation of liver enzyme was observed in 2 patients after 3 doses of Lorelin(R). Side effects were mainly due to treatment-induced hypoestrogenism and the most frequent symptom was hot flush (55%), vaginal dryness (30%), transient nausea sense (25%), and arthralgia (25%). All patients were able to tolerate these symptoms and no one discontinued Lorelin(R) therapy.
CONCLUSION
This study suggests that Lorelin(R) could be an effective and safe regimen in the treatment of endometriosis.