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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03204331
Registration number
NCT03204331
Ethics application status
Date submitted
27/06/2017
Date registered
2/07/2017
Titles & IDs
Public title
SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
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Scientific title
SPIRIT 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain
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Secondary ID [1]
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2017-001632-19
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Secondary ID [2]
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MVT-601-3102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis Related Pain
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Condition category
Condition code
Reproductive Health and Childbirth
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0
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Other reproductive health and childbirth disorders
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Reproductive Health and Childbirth
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0
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Relugolix
Treatment: Drugs - Estradiol/norethindrone acetate
Treatment: Drugs - Estradiol/norethindrone acetate placebo
Treatment: Drugs - Relugolix placebo
Experimental: Relugolix plus E2/NETA (Group A) - Relugolix co-administered with E2/NETA for 24 weeks.
Experimental: Relugolix plus Delayed E2/NETA (Group B) - Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
Placebo comparator: Placebo (Group C) - Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.
Treatment: Drugs: Relugolix
Relugolix 40-mg tablet administered orally once daily.
Treatment: Drugs: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
Treatment: Drugs: Estradiol/norethindrone acetate placebo
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.
Treatment: Drugs: Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT)
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Assessment method [1]
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Assessed using a Numerical Rating Scale (NRS) score (11-point scale) for pain recorded daily in an electronic diary (e-Diary). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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Timepoint [1]
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Week 24 or EOT
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Primary outcome [2]
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Percentage Of Participants Who Meet The Non-Menstrual Pelvic Pain (NMPP) Responder Criteria At Week 24 Or EOT
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Assessment method [2]
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Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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Timepoint [2]
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Week 24 or EOT
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Secondary outcome [1]
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Change From Baseline In The Endometriosis Health Profile (EHP)-30 Pain Score At Week 24
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Assessment method [1]
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Assessed using the Pain Domain of the EHP-30 questionnaire.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Change From Baseline In Dysmenorrhea NRS Score At Week 24 Or EOT
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Assessment method [2]
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Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
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Timepoint [2]
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Baseline, Week 24 or EOT
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Secondary outcome [3]
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Change From Baseline In NMPP NRS Score At Week 24 Or EOT
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Assessment method [3]
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Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
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Timepoint [3]
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Baseline, Week 24 or EOT
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Secondary outcome [4]
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Change From Baseline In Overall Pelvic Pain NRS Score At Week 24 Or EOT
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Assessment method [4]
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Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
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Timepoint [4]
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Baseline, Week 24 or EOT
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Secondary outcome [5]
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Change From Baseline In Dyspareunia NRS Scores At Week 24 Or EOT
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Assessment method [5]
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Assessed using an NRS score (11-point scale) for dyspareunia recorded daily in an e-Diary.
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Timepoint [5]
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Baseline, Week 24 or EOT
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Secondary outcome [6]
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Percentage Of Participants Who Are Not Using Opioids For Endometriosis-associated Pain At Week 24 Or EOT
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Assessment method [6]
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Assessed based on usage of protocol-specified opioids for endometriosis-associated pain recorded daily in an e-Diary.
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Timepoint [6]
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Week 24 or EOT
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Secondary outcome [7]
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Change From Baseline In Analgesic Use For Endometriosis-associated Pain Based On Mean Pill Count At Week 24 Or EOT
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Assessment method [7]
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Assessed based on usage of protocol-specified analgesic for endometriosis-associated pain recorded daily in an e-Diary.
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Timepoint [7]
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Baseline, Week 24 or EOT
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Secondary outcome [8]
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Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24
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Assessment method [8]
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Assessed using the pain domain of the EHP-30 questionnaire.
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Timepoint [8]
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Baseline to Week 24
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Secondary outcome [9]
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Dysmenorrhea Responder Rate By Month
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Assessment method [9]
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The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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Timepoint [9]
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Baseline to Week 24
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Secondary outcome [10]
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NMPP Responder Rate By Month
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Assessment method [10]
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The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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Timepoint [10]
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Baseline to Week 24
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Secondary outcome [11]
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Change In Dysmenorrhea NRS Score By Month
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Assessment method [11]
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Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
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Timepoint [11]
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Baseline to Week 24
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Secondary outcome [12]
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Change In NMPP NRS Score By Month
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Assessment method [12]
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0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
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Timepoint [12]
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Baseline to Week 24
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Secondary outcome [13]
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Change In Overall Pelvic Pain NRS Score By Month
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Assessment method [13]
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0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
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Timepoint [13]
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0
Baseline to Week 24
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Secondary outcome [14]
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Change In Dyspareunia NRS Score By Month
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Assessment method [14]
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0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
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Timepoint [14]
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Baseline to Week 24
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Secondary outcome [15]
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Change From Baseline In Ibuprofen Use At Week 24 Or EOT
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Assessment method [15]
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Assessed using ibuprofen pill counts for endometriosis-associated pain recorded daily in an e-Diary.
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Timepoint [15]
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Baseline, Week 24
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Secondary outcome [16]
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Change From Baseline In Opioid Use At Week 24 Or EOT
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Assessment method [16]
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Assessed using opioid pill counts for endometriosis-associated pain recorded daily in an e-Diary.
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Timepoint [16]
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Baseline, Week 24
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Secondary outcome [17]
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Change From Baseline In The Mean Dysmenorrhea Functional Impairment At Week 24 Or EOT
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Assessment method [17]
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Assessed using the subject modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an e-Diary.
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Timepoint [17]
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Baseline, Week 24 or EOT
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Secondary outcome [18]
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Change From Baseline In The Mean NMPP Functional Impairment At Week 24 Or EOT
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Assessment method [18]
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Assessed using the subject modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an e-Diary.
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Timepoint [18]
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0
Baseline, Week 24 or EOT
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Secondary outcome [19]
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Change From Baseline In The Mean Dyspareunia Functional Impairment At Week 24 Or EOT
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Assessment method [19]
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0
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an e-Diary.
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Timepoint [19]
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0
Baseline, Week 24 or EOT
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Secondary outcome [20]
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0
Change From Baseline In Patient Global Assessment (PGA) For Dysmenorrhea Symptom Severity At Week 24
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Assessment method [20]
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The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
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Timepoint [20]
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0
Baseline, Week 24
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Secondary outcome [21]
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Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Dysmenorrhea At Week 24
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Assessment method [21]
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The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
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Timepoint [21]
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Week 24
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Secondary outcome [22]
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Change From Baseline In PGA For NMPP Symptom Severity At Week 24
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Assessment method [22]
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The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
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Timepoint [22]
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0
Baseline, Week 24
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Secondary outcome [23]
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Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For NMPP At Week 24
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Assessment method [23]
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0
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
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Timepoint [23]
0
0
Week 24
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Secondary outcome [24]
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Change From Baseline In PGA For Pain Severity At Week 24
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Assessment method [24]
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The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
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Timepoint [24]
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Baseline, Week 24
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Secondary outcome [25]
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Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Pain Severity At Week 24
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Assessment method [25]
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The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
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Timepoint [25]
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Week 24
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Secondary outcome [26]
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Change From Baseline In PGA For Function At Week 24
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Assessment method [26]
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The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
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Timepoint [26]
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Baseline, Week 24
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Secondary outcome [27]
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Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Function At Week 24
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Assessment method [27]
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The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
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Timepoint [27]
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0
Week 24
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Secondary outcome [28]
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Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 24
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Assessment method [28]
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The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during their menstrual cycle.
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Timepoint [28]
0
0
Week 24
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Secondary outcome [29]
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Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 24
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Assessment method [29]
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The PGIC for NMPP is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during their menstrual cycle.
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Timepoint [29]
0
0
Week 24
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Secondary outcome [30]
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Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 24
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Assessment method [30]
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The PGIC for dyspareunia is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during sexual intercourse.
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Timepoint [30]
0
0
Week 24
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Secondary outcome [31]
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Change From Baseline In The Non-Pain Of The EHP-30 Domains At Week 24
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Assessment method [31]
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Assessed using the non-pain domains (Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image) of the EHP-30 questionnaire.
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Timepoint [31]
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Baseline, Week 24
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Secondary outcome [32]
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Change From Baseline In The EHP-30 Scale Total Score At Week 24
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Assessment method [32]
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Assessed using the total score of the EHP-30 questionnaire.
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Timepoint [32]
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Baseline, Week 24
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Secondary outcome [33]
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Change From Baseline In The EHP Work Domain Score At Week 24
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Assessment method [33]
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The EHP Work domain is a 5-item questionnaire that assesses impact of pain on ability to work.
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Timepoint [33]
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Baseline, Week 24
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Secondary outcome [34]
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Categorical Change From Baseline In Quality Of Life Assessed By European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Questionnaire At Week 24
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Assessment method [34]
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The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
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Timepoint [34]
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Baseline, Week 24
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Secondary outcome [35]
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Change From Baseline To Week 24 In EQ-5D-5L Visual Analogue Scale Score At Week 24
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Assessment method [35]
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The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
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Timepoint [35]
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Baseline, Week 24
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Secondary outcome [36]
0
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Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
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Assessment method [36]
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0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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Timepoint [36]
0
0
Week 24 or EOT
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Secondary outcome [37]
0
0
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
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Assessment method [37]
0
0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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Timepoint [37]
0
0
Week 24 or EOT
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Secondary outcome [38]
0
0
Change From Baseline In The EHP-30 Pain Score At Week 24 For Relugolix Plus Delayed E2/NETA
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Assessment method [38]
0
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Assessed using the Pain Domain of the EHP-30 questionnaire.
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Timepoint [38]
0
0
Baseline, Week 24
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Secondary outcome [39]
0
0
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24 For Relugolix Plus Delayed E2/NETA
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Assessment method [39]
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Assessed using the pain domain of the EHP-30 questionnaire.
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Timepoint [39]
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0
Baseline to Week 24
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Secondary outcome [40]
0
0
Percentage Change From Baseline In Bone Mineral Density At The Lumbar Spine (L1-L4) At Week 12
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Assessment method [40]
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Assessed by dual-energy X-ray absorptiometry (DXA) scan.
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Timepoint [40]
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0
Baseline, Week 12
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Secondary outcome [41]
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0
Percentage Change From Baseline In Bone Mineral Density At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 24
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Assessment method [41]
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0
Assessed by DXA scan.
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Timepoint [41]
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0
Baseline, Week 24
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Secondary outcome [42]
0
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Percentage Of Participants Experiencing Vasomotor Symptoms At Week 12 Between Group A And B
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Assessment method [42]
0
0
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Timepoint [42]
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0
Week 12
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Secondary outcome [43]
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Change From Baseline In Serum Concentrations Of Luteinizing Hormone, Follicle Stimulating Hormone, Estradiol, And Progesterone
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Assessment method [43]
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Blood samples will be collected from participants for hormonal measurements.
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Timepoint [43]
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Baseline, Week 24
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Eligibility
Key inclusion criteria
Key
1. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form.
2. Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
3. Has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy.
4. During the Run-In Period (35 to 70 days prior to treatment period) has a dysmenorrhea NRS score = 4.0 on at least 2 days and
1. Mean NMPP NRS score = 2.5, or
2. Mean NMPP NRS score = 1.25 and NMPP NRS score = 5.0 on = 4 days.
Key
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Has a history of chronic pelvic pain that is not caused by endometriosis.
2. Has any chronic pain or frequently recurring pain condition, other than endometriosis that is treated with opioids or requires analgesics for = 7 days per month.
3. Has had surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit.
4. Has a history of or currently has osteoporosis or other metabolic bone disease.
5. Has a clinically significant gynecologic condition, other than endometriosis, identified during Screening or Run-In period transvaginal ultrasound or endometrial biopsy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2021
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Sample size
Target
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Accrual to date
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Final
623
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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0
Sydney - Sydney
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Recruitment hospital [2]
0
0
Wollongong - Wollongong
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Recruitment hospital [3]
0
0
Sherwood - Sherwood
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Recruitment hospital [4]
0
0
Adelaide - Adelaide
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Recruitment hospital [5]
0
0
Nedlands - Nedlands
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Recruitment postcode(s) [1]
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0
2000 - Sydney
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Recruitment postcode(s) [2]
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0
2522 - Wollongong
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Recruitment postcode(s) [3]
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0
4075 - Sherwood
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Recruitment postcode(s) [4]
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0
5000 - Adelaide
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Recruitment postcode(s) [5]
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0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
District of Columbia
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Idaho
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Louisiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Maryland
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Michigan
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Missouri
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Nebraska
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New Mexico
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Country [14]
0
0
United States of America
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State/province [14]
0
0
New York
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Country [15]
0
0
United States of America
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State/province [15]
0
0
North Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Ohio
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Country [17]
0
0
United States of America
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State/province [17]
0
0
South Carolina
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Tennessee
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Texas
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Utah
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Virginia
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Country [22]
0
0
Brazil
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State/province [22]
0
0
RIO Grande DO SUL
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Country [23]
0
0
Brazil
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State/province [23]
0
0
Rio Grande Do Sul
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Country [24]
0
0
Brazil
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State/province [24]
0
0
SAO Paulo
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Country [25]
0
0
Chile
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Georgia
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Borjomi
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Italy
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Italy
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Pavia
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Italy
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Roma
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Poland
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Slaskie
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Brasov
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Sweden
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Skane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Myovant Sciences GmbH
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.
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Trial website
https://clinicaltrials.gov/study/NCT03204331
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Trial related presentations / publications
Giudice LC, As-Sanie S, Arjona Ferreira JC, Becker CM, Abrao MS, Lessey BA, Brown E, Dynowski K, Wilk K, Li Y, Mathur V, Warsi QA, Wagman RB, Johnson NP. Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2). Lancet. 2022 Jun 18;399(10343):2267-2279. doi: 10.1016/S0140-6736(22)00622-5. Erratum In: Lancet. 2022 Aug 27;400(10353):660. doi: 10.1016/S0140-6736(22)01581-1.
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Public notes
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Contacts
Principal investigator
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Myovant Medical Monitor
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Myovant Sciences
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03204331