SR-16234, a Novel Selective Estrogen Receptor Modulator for Pain Symptoms with Endometriosis: An Open-label Clinical Trial.

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AI-generated summary by claude@2026-06, 2026-06-08

This open-label trial found that 12 weeks of SR-16234 treatment significantly reduced pelvic pain and dysmenorrhea in endometriosis patients compared to baseline.

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AI-generated deep summary by claude@2026-06, 2026-06-09 · read from full text

This open-label, single-arm clinical trial evaluated the efficacy and safety of SR-16234, a selective estrogen receptor modulator with reported ERα antagonistic and ERβ partial agonistic activity, for pain symptoms in endometriosis and adenomyosis patients. Ten participants with dysmenorrhea and pelvic pain associated with endometriosis and adenomyosis received 40 mg SR-16234 once daily for 12 weeks, with pelvic pain VAS as the primary endpoint and secondary assessments including dysmenorrhea scores, pelvic pain scores, objective observations (e.g., Douglas’ pouch stiffness, uterine movement limitation, ovarian chocolate cyst size, endometrial thickness, and serum CA125), and safety. After 12 weeks, baseline comparisons showed statistically significant decreases in pelvic pain VAS and total pelvic pain and dysmenorrhea scores, as well as improvements in several objective measures. The study’s main caveat is its small sample size and lack of a control group, limiting causal inference. This paper is centrally about endometriosis — it reports a clinical trial of SR-16234 for pain associated with endometriosis (and includes adenomyosis patients as well).

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Abstract

Background: SR-16234 is a selective estrogen receptor modulator (SERM) structurally different from approved SERM and has been reported to have estrogen receptor (ER) α antagonistic activity and strong affinity with a weak partial agonistic activity to ERβ receptor. SR-16234 showed strong inhibitory effects on transplanted endometrial cysts in the endometriosis model of rat and mouse. In this clinical trial, efficacy and safety of SR-16234 have been evaluated in endometriosis patients. Methods: This trial was an open-label single arm clinical trial. Ten patients with dysmenorrhea and pelvic pain associated with endometriosis and adenomyosis were enrolled in this trial, and received 40 mg of SR-16234 once daily for 12 weeks. The primary endpoint was the visual analogue scale (VAS) of pelvic pain. The secondary endpoints included dysmenorrhea score, pelvic pain score, objective observations (stiffness of Douglas' pouch, limitation of uterine movement, size of ovarian chocolate cysts, thickness of endometrium, and serum CA125 concentration) and safety. Results: After oral administration of SR-16234 40 mg for 12 weeks, there were statistically significant decreases in pelvic pain VAS, total pelvic pain score, total dysmenorrhea score, stiffness of Douglas' pouch, limitation of uterine movement compared with the baseline values. Conclusion: The present trial suggested that a selective estrogen receptor modulator could be used for treatment of pain associated with endometriosis for the first time.
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WEKO3 アイテム SR-16234, a Novel Selective Estrogen Receptor Modulator for Pain Symptoms with Endometriosis: An Open-label Clinical Trial https://repository.lib.tottori-u.ac.jp/records/4876 https://repository.lib.tottori-u.ac.jp/records/487649e5fcec-7343-41f3-881e-58c36b5b1858 | 名前 / ファイル | ライセンス | アクション | |---|---|---| | yam60(4)_227.pdf (702.1 kB) | | | アイテムタイプ | 学術雑誌論文 / Journal Article(1) | ||||||||| |---|---|---|---|---|---|---|---|---|---|---| | 公開日 | 2018-06-22 | ||||||||| | タイトル | |||||||||| | タイトル | SR-16234, a Novel Selective Estrogen Receptor Modulator for Pain Symptoms with Endometriosis: An Open-label Clinical Trial | ||||||||| | 言語 | en | ||||||||| | 言語 | |||||||||| | 言語 | eng | ||||||||| | キーワード | |||||||||| | 主題 | estrogen receptor | ||||||||| | キーワード | |||||||||| | 主題 | endometriosis | ||||||||| | キーワード | |||||||||| | 主題 | selective estrogen receptor modulator | ||||||||| | キーワード | |||||||||| | 主題 | pelvic pain | ||||||||| | キーワード | |||||||||| | 主題 | open clinical trial | ||||||||| | キーワード | |||||||||| | 言語 | en | ||||||||| | 主題 | estrogen receptor | ||||||||| | キーワード | |||||||||| | 言語 | en | ||||||||| | 主題 | endometriosis | ||||||||| | キーワード | |||||||||| | 言語 | en | ||||||||| | 主題 | selective estrogen receptor modulator | ||||||||| | キーワード | |||||||||| | 言語 | en | ||||||||| | 主題 | pelvic pain | ||||||||| | キーワード | |||||||||| | 言語 | en | ||||||||| | 主題 | open clinical trial | ||||||||| | 資源タイプ | |||||||||| | 資源タイプ | journal article | ||||||||| | 著者 | Harada, Tasuku × Harada, Tasuku× Ohta, Ikuko× Endo, Yusuke× Sunada, Hiroshi× Noma, Hisashi× Taniguchi, Fuminori WEKO 3792 × Ohta, Ikuko× Noma, Hisashi | ||||||||| | 著者所属 | |||||||||| | 値 | Department of Obstetrics and Gynecology, School of Medicine, Tottori University Faculty of Medicine | ||||||||| | 著者所属 | |||||||||| | 値 | Department of Obstetrics and Gynecology, Kurashiki Heisei Hospital | ||||||||| | 著者所属 | |||||||||| | 値 | Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital | ||||||||| | 著者所属 | |||||||||| | 値 | Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital | ||||||||| | 著者所属 | |||||||||| | 値 | Department of Data Science, The Institute of Statistical Mathematics | ||||||||| | 著者所属 | |||||||||| | 値 | Department of Obstetrics and Gynecology, School of Medicine, Tottori University Faculty of Medicine | ||||||||| | 著者所属(英) | |||||||||| | 言語 | en | ||||||||| | 値 | Department of Obstetrics and Gynecology, School of Medicine, Tottori University Faculty of Medicine | ||||||||| | 著者所属(英) | |||||||||| | 言語 | en | ||||||||| | 値 | Department of Obstetrics and Gynecology, Kurashiki Heisei Hospital | ||||||||| | 著者所属(英) | |||||||||| | 言語 | en | ||||||||| | 値 | Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital | ||||||||| | 著者所属(英) | |||||||||| | 言語 | en | ||||||||| | 値 | Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital | ||||||||| | 著者所属(英) | |||||||||| | 言語 | en | ||||||||| | 値 | Department of Data Science, The Institute of Statistical Mathematics | ||||||||| | 著者所属(英) | |||||||||| | 言語 | en | ||||||||| | 値 | Department of Obstetrics and Gynecology, School of Medicine, Tottori University Faculty of Medicine | ||||||||| | 抄録 | |||||||||| | 内容記述タイプ | Other | ||||||||| | 内容記述 | [Background]SR-16234 is a selective estrogen receptor modulator (SERM) structurally different from approved SERM and has been reported to have estrogen receptor (ER) α antagonistic activity and strong affinity with a weak partial agonistic activity to ERβ receptor. SR-16234 showed strong inhibitory effects on transplanted endometrial cysts in the endometriosis model of rat and mouse. In this clinical trial, efficacy and safety of SR-16234 have been evaluated in endometriosis patients. [Methods]This trial was an open-label single arm clinical trial. Ten patients with dysmenorrhea and pelvic pain associated with endometriosis and adenomyosis were enrolled in this trial, and received 40 mg of SR-16234 once daily for 12 weeks. The primary endpoint was the visual analogue scale (VAS) of pelvic pain. The secondary endpoints included dysmenorrhea score, pelvic pain score, objective observations (stiffness of Douglas’ pouch, limitation of uterine movement, size of ovarian chocolate cysts, thickness of endometrium, and serum CA125 concentration) and safety. [Results]After oral administration of SR-16234 40 mg for 12 weeks, there were statistically significant decreases in pelvic pain VAS, total pelvic pain score, total dysmenorrhea score, stiffness of Douglas’ pouch, limitation of uterine movement compared with the baseline values. [Conclusion]The present trial suggested that a selective estrogen receptor modulator could be used for treatment of pain associated with endometriosis for the first time. | ||||||||| | 書誌情報 | Yonago Acta Medica en : Yonago Acta Medica 巻 60, 号 4, p. 227-223, 発行日 2018-02-05 | ||||||||| | 出版者 | |||||||||| | 出版者 | Tottori University Faculty of Medicine | ||||||||| | ISSN | |||||||||| | 収録物識別子タイプ | ISSN | ||||||||| | 収録物識別子 | 05135710 | ||||||||| | 書誌レコードID | |||||||||| | 収録物識別子タイプ | NCID | ||||||||| | 収録物識別子 | AA00892882 | ||||||||| | DOI | |||||||||| | 関連タイプ | isIdenticalTo | ||||||||| | 識別子タイプ | DOI | ||||||||| | 関連識別子 | 10.33160/yam.2017.12.003 | ||||||||| | 権利 | |||||||||| | 権利情報 | Yonago Acta medica 編集委員会 | ||||||||| | 情報源 | |||||||||| | 関連名称 | Yonago Acta Medica. 2017, 60(4), 227-223 | ||||||||| | 関連サイト | |||||||||| | 識別子タイプ | URI | ||||||||| | 関連識別子 | http://www.lib.tottori-u.ac.jp/yam/yam/yam60-4/60-4contents.html | ||||||||| | 関連名称 | http://www.lib.tottori-u.ac.jp/yam/yam/yam60-4/60-4contents.html | ||||||||| | 著者版フラグ | |||||||||| | 出版タイプ | VoR | ||||||||| | EISSN | |||||||||| | 値 | 1346-8049 |

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Outcome instruments

VAS-pain

Condition tags

endometriosisadenomyosisdysmenorrhea

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