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Background
Leuprolide acetate is a gonadotropin-releasing hormone agonist (GnRHa) and a treatment option for endometriosis, but it is not approved for use beyond 12 months due to the potential long-term side effects on bone density. Small cohort studies in adults have demonstrated “off label” use beyond this timeframe, and it is unknown if GnRHa is continued for long-term use in adolescents. Additionally, alternative treatment options following GnRHa discontinuation are poorly understood. This study aimed to describe the long-term use of leuprolide acetate in adolescents with endometriosis and to explore the treatment course after its discontinuation.
Methods
We identified 51 subjects with laparoscopically-confirmed endometriosis who had participated in a year-long randomized clinical trial of GnRHa plus add-back as adolescents between 2008-2012. Electronic medical records were reviewed to obtain demographic data, clinical characteristics, and treatment outcomes following trial completion. The study was deemed IRB exempt.
Results
The average age of participants during trial enrollment was 17.9 ± 1.7 y. Thirty-three participants had stage I endometriosis (65%), whereas n=18 had stage II endometriosis (35%). The most common treatments trialed before GnRHa were combined oral contraceptive pills (n=47, 92%) and progestin-only pills (n=23, 45%). The average duration of GnRHa use during the trial was 9.5 ± 3.5 months; 34 subjects (67%) completed the one-year trial. After completion of the one-year trial, 23 subjects (45%) continued to use GnRHa with add back therapy. Mean duration of GnRHa use after trial completion was an additional 31.7 ± 28.6 months, and the longest identified duration an additional 96 months. Twenty-four subjects switched to other hormonal treatments after trial participation, most commonly oral progestins (n=15) or combined oral contraceptives (n=6). Thirteen participants (25%) returned to a therapy that had been trialed before GnRHa.
Conclusions
Almost half the participants continued to utilize GnRHa with steroid add-back beyond the 12-month recommended duration. As there are no data supporting one treatment over another, the treatment choice utilized by each subject varied widely after discontinuation of GnRHa, with many returning to previously trialed medical therapies.
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© 2023 Published by Elsevier Inc.
