A study on the efficacy and safety of long-term adjusted low-dose gonadotropin-releasing hormone agonist therapy for uterine fibroids and adenomyosis

Soichiro Kashiwabara, Shinichiro Yabe, Yabe S, Kouki Samejima, Narita T, Tatsuya Narita, Yukiko Itaya, Itaya Y, Era S, Sumiko Era, Shigetaka Matsunaga, Tomonori Nagai, Nagai T, Kikuchi A, Akihiko Kikuchi, Yasushi Takai
Journal of Obstetrics and Gynaecology Research · 2024 · vol. 50(12) , pp. 2319–2326 · doi:10.1111/jog.16128 · PMID:39462178
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⚙ AI-generated summary by claude@2026-06, 2026-06-12 ⓘ

This study found that long-term adjusted low-dose nafarelin acetate therapy for uterine fibroids and adenomyosis effectively stopped menstruation, increased hemoglobin, and was safe, with minimal effects on bone density.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-12 · read from full text ⓘ

This single-center retrospective observational study evaluated long-term adjusted low-dose GnRH agonist “drawback therapy” using nafarelin acetate in 118 patients with uterine fibroids and/or adenomyosis who had menstrual symptoms, with outcomes assessed before treatment and after initiation (including hemoglobin, fibroid diameter, corpus uteri area, estradiol levels, nafarelin dose over time, and lumbar/femoral neck bone density). During a median follow-up of 28 months, menstruation ceased in all patients, and hemoglobin levels increased significantly in both fibroid and adenomyosis groups, while treatment did not show significant shrinking of fibroids or adenomyosis; importantly, increased size was not observed in any patient. Estradiol suppression to <30 pg/mL occurred in 25% of patients, and average bone density changes over 6 months were reported as lower than previously reported rates. The paper’s limitations include its retrospective design and single-center data, and it does not publicly share data due to privacy/ethical restrictions. This paper is centrally about adenomyosis — it specifically investigates long-term low-dose nafarelin acetate drawback therapy for adenomyosis-related menstrual symptoms and reports hemoglobin and bone density outcomes in the adenomyosis subgroup.

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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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Condition tags

adenomyosis

MeSH descriptors

Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis

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