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

Tasuku Harada, Ikuko Ohta, Yusuke Endo, Hiroshi Sunada, Hisashi Noma, Fuminori Taniguchi
In: Yonago Acta Medica · 2017 · vol. 60(4) , pp. 227–233 · doi:10.33160/yam.2017.12.003 · W4251048761
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This open-label trial evaluated SR-16234 in 10 endometriosis patients, finding significant reductions in pelvic pain, dysmenorrhea, and physical limitations after 12 weeks of treatment.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-08 · read from full text ⓘ

This open-label, single-arm clinical trial evaluated SR-16234, a novel selective estrogen receptor modulator with reported ERα antagonistic activity and weak partial agonism at ERβ, in 10 patients with dysmenorrhea and pelvic pain associated with endometriosis and adenomyosis. Participants received 40 mg once daily for 12 weeks, and the primary endpoint was change in pelvic pain measured by visual analogue scale, with secondary endpoints including dysmenorrhea and pelvic pain scores, objective measures (e.g., Douglas’ pouch stiffness, uterine movement limitation, ovarian chocolate cyst size, endometrium thickness, and serum CA125), and safety. After treatment, the study reported statistically significant decreases from baseline in pelvic pain VAS, total pelvic pain score, total dysmenorrhea score, and several objective findings related to pelvic/uterine mobility. The paper notes the trial’s design as open-label and single-arm and therefore does not include a randomized control, and it is centrally about endometriosis—specifically, evaluating SR-16234 for pain symptoms in endometriosis patients who also included adenomyosis.

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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 clini- cal 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 sec- ondary 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 decreas- es in pelvic pain VAS, total pelvic pain score, total dys- menorrhea 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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Keywords

estrogen receptor, endometriosis, selective estrogen receptor modulator, pelvic pain, open clinical trial 2017 Volume 60 Issue 4 Pages 227-233 Details

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 clini- cal 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 sec- ondary 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 decreas- es in pelvic pain VAS, total pelvic pain score, total dys- menorrhea 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. 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 clini- cal 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 sec- ondary 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 decreas- es in pelvic pain VAS, total pelvic pain score, total dys- menorrhea 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. © 2017 Tottori University Faculty of Medicine Favorites & Alerts Recently viewed articles

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Outcome instruments

VAS-pain

Condition tags

endometriosisadenomyosisdysmenorrhea

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