A study on the efficacy and safety of long-term adjusted low-dose gonadotropin-releasing hormone agonist therapy for uterine fibroids and adenomyosis
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Abstract
AIM: To investigate the efficacy and safety of long-term adjusted low-dose gonadotropin-releasing hormone agonist therapy (GnRH agonist drawback therapy) with nafarelin acetate in patients with uterine fibroids and/or adenomyosis with menstrual symptoms.
METHODS: This single-center, retrospective, observational study initially included 118 patients with uterine fibroids and/or adenomyosis with menstrual symptoms who had received GnRH agonist (nafarelin acetate) drawback therapy for at least 7 months between 2010 and 2020. Blood hemoglobin level, maximum fibroid diameter, area of the corpus uteri, blood estradiol level, daily dosage of nafarelin acetate, and bone density in the lumbar spine and femoral neck were assessed before and after the treatment initiation.
RESULTS: The median treatment period was 28 months. Menstruation had ceased in all patients. The median hemoglobin level significantly increased from 8.6 to 13.2 g/dL before treatment and at 12 months after the treatment initiation in patients with fibroids and from 8.8 to 13.3 g/dL in patients with adenomyosis, respectively. Although the treatment did not exert a significant shrinking effect on the fibroids and adenomyosis, an increase in their size was not observed in any patient. The initial dose of nafarelin acetate was 400 μg/day and was lowered to 130 μg/day at 12 months. Only 29 patients (25%) had an estradiol level <30 pg/mL. The average rate of bone density change over 6 months was -1.23% in the lumbar spine and -1.12% in the femoral neck in patients with fibroids and -1.06% in the lumbar spine and -0.14% in the femoral neck in patients with adenomyosis, which were lower than the previously reported rates.
CONCLUSIONS: GnRH agonist drawback therapy was found to be useful for the long-term conservative treatment of uterine fibroids and adenomyosis. The treatment was safely and inexpensively performed with few adverse events.
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Abstract
Aim
To investigate the efficacy and safety of long-term adjusted low-dose gonadotropin-releasing hormone agonist therapy (GnRH agonist drawback therapy) with nafarelin acetate in patients with uterine fibroids and/or adenomyosis with menstrual symptoms.
Methods
This single-center, retrospective, observational study initially included 118 patients with uterine fibroids and/or adenomyosis with menstrual symptoms who had received GnRH agonist (nafarelin acetate) drawback therapy for at least 7 months between 2010 and 2020.
Blood hemoglobin level, maximum fibroid diameter, area of the corpus uteri, blood estradiol level, daily dosage of nafarelin acetate, and bone density in the lumbar spine and femoral neck were assessed before and after the treatment initiation.
Results
The median treatment period was 28 months. Menstruation had ceased in all patients. The median hemoglobin level significantly increased from 8.6 to 13.2 g/dL before treatment and at 12 months after the treatment initiation in patients with fibroids and from 8.8 to 13.3 g/dL in patients with adenomyosis, respectively. Although the treatment did not exert a significant shrinking effect on the fibroids and adenomyosis, an increase in their size was not observed in any patient. The initial dose of nafarelin acetate was 400 μg/day and was lowered to 130 μg/day at 12 months. Only 29 patients (25%) had an estradiol level <30 pg/mL. The average rate of bone density change over 6 months was −1.23% in the lumbar spine and −1.12% in the femoral neck in patients with fibroids and −1.06% in the lumbar spine and −0.14% in the femoral neck in patients with adenomyosis, which were lower than the previously reported rates.
Conclusions
GnRH agonist drawback therapy was found to be useful for the long-term conservative treatment of uterine fibroids and adenomyosis. The treatment was safely and inexpensively performed with few adverse events.
CONFLICT OF INTEREST STATEMENT
Dr. Yasushi Takai is an Editorial Board member of JOG Journal and a coauthor of this article. To minimize bias, they were excluded from all editorial decision-making related to the acceptance of this article for publication. Other author have no conflict of interest.
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are not publicly available due to privacy/ethical restrictions of our ethics committee. Although the data are anonymized, a new ethical review carried out by our institute is required for the secondary use of these data. if the corresponding author receive a request to provide the data, he will discuss the matter again with the ethics committee.
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Courtesy of the U.S. National Library of Medicine
Courtesy of the U.S. National Library of Medicine