Fertility and Sterility
 2021
DOI: 10.1016/j.fertnstert.2020.07.055
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Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose–response manner: a randomized, double-blind, placebo-controlled study

Yutaka Osuga
1
,
Yoshifumi Seki
2
,
Masataka Tanimoto
3
et al.

Abstract: Objective: To evaluate the efficacy and safety of three dose levels of relugolix, a gonadotropin-releasing hormone receptor antagonist, compared with placebo and leuprorelin in women with endometriosis-associated pain. Design: Phase 2, multicenter, randomized, double-blind, placebo-controlled study. Setting: Hospitals and clinics. Patient(s): Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain. Intervention(s): During a 12-week treatment period, patients r… Show more

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Cited by 94 publications

(73 citation statements)
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“…The incidence of TEAEs was similar in both groups, and we concluded that the drug-related TEAEs of headache, hot flush, metrorrhagia, and genital hemorrhage most likely resulted from the reduced estrogen levels by these drugs. In addition, the severity of uterine bleeding as a TEAE in the REL group was considered mild, whereas the decrease in BMD was similar in both groups and consistent with earlier results (13).…”
Section: Discussionsupporting
confidence: 90%
“…Therefore, we concluded that the efficacy of REL for treating pelvic pain and related symptoms was similar to that of LEU, confirming the results obtained in the phase 2 dosefinding study (13).…”
Section: Discussionsupporting
confidence: 86%
See 1 more Smart Citation
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
“…The incidence of TEAEs was similar in both groups, and we concluded that the drug-related TEAEs of headache, hot flush, metrorrhagia, and genital hemorrhage most likely resulted from the reduced estrogen levels by these drugs. In addition, the severity of uterine bleeding as a TEAE in the REL group was considered mild, whereas the decrease in BMD was similar in both groups and consistent with earlier results (13).…”
Section: Discussionsupporting
confidence: 90%
“…Therefore, we concluded that the efficacy of REL for treating pelvic pain and related symptoms was similar to that of LEU, confirming the results obtained in the phase 2 dosefinding study (13).…”
Section: Discussionsupporting
confidence: 86%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
“…The incidence of hot flushes was higher during the first 12-week period (six out of eight women) compared to only one woman during the second 12-week period. Similar dose-related differences were observed in a previous study [29]. There were no changes in HDL cholesterol, LDL cholesterol, or cholesterol and triglyceride levels, which remained in the normal range from baseline to week 24.…”
Section: Discussionsupporting
confidence: 88%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
“…The majority of the TEAEs experienced by patients treated with relugolix were mild, and TEAEs leading to study drug discontinuation were uncommon. These safety and efficacy results over 24 weeks were consistent with the findings from the first 12 weeks of the phase 2 study [ 12 ].…”
Section: Discussionsupporting
confidence: 86%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
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