Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT) |
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. |
Week 24 or EOT |
|
| Primary |
Percentage Of Participants Who Meet The Non-Menstrual Pelvic Pain (NMPP) Responder Criteria At Week 24 Or EOT |
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. |
Week 24 or EOT |
|
| Secondary |
Change From Baseline In The Endometriosis Health Profile (EHP)-30 Pain Score At Week 24 |
Assessed using the Pain Domain of the EHP-30 questionnaire. |
Baseline, Week 24 |
|
| Secondary |
Change From Baseline In Dysmenorrhea NRS Score At Week 24 Or EOT |
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Change From Baseline In NMPP NRS Score At Week 24 Or EOT |
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Change From Baseline In Overall Pelvic Pain NRS Score At Week 24 Or EOT |
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Percentage Of Participants Who Are Not Using Opioids For Endometriosis-associated Pain At Week 24 Or EOT |
Assessed based on usage of protocol-specified opioids for endometriosis-associated pain recorded daily in an e-Diary. |
Week 24 or EOT |
|
| Secondary |
Change From Baseline In Dyspareunia NRS Scores At Week 24 Or EOT |
Assessed using an NRS score (11-point scale) for dyspareunia recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Change From Baseline In Analgesic Use For Endometriosis-associated Pain Based On Mean Pill Count At Week 24 Or EOT |
Assessed based on usage of protocol-specified analgesic for endometriosis-associated pain recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24 |
Assessed using the pain domain of the EHP-30 questionnaire. |
Baseline to Week 24 |
|
| Secondary |
Dysmenorrhea Responder Rate By Month |
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
Baseline to Week 24 |
|
| Secondary |
NMPP Responder Rate By Month |
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
Baseline to Week 24 |
|
| Secondary |
Change In Dysmenorrhea NRS Score By Month |
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. |
Baseline to Week 24 |
|
| Secondary |
Change In NMPP NRS Score By Month |
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. |
Baseline to Week 24 |
|
| Secondary |
Change In Overall Pelvic Pain NRS Score By Month |
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. |
Baseline to Week 24 |
|
| Secondary |
Change In Dyspareunia NRS Score By Month |
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. |
Baseline to Week 24 |
|
| Secondary |
Change From Baseline In Ibuprofen Use At Week 24 Or EOT |
Assessed using ibuprofen pill counts for endometriosis-associated pain recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Change From Baseline In Opioid Use At Week 24 Or EOT |
Assessed using opioid pill counts for endometriosis-associated pain recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Change From Baseline In The Mean Dysmenorrhea Functional Impairment At Week 24 Or EOT |
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Change From Baseline In The Mean NMPP Functional Impairment At Week 24 Or EOT |
Assessed using the subject modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Change From Baseline In The Mean Dyspareunia Functional Impairment At Week 24 Or EOT |
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an e-Diary. |
Baseline, Week 24 or EOT |
|
| Secondary |
Change From Baseline In Patient Global Assessment (PGA) For Dysmenorrhea Symptom Severity At Week 24 |
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle. |
Baseline, Week 24 |
|
| Secondary |
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Dysmenorrhea At Week 24 |
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle. |
Week 24 |
|
| Secondary |
Change From Baseline In PGA For NMPP Symptom Severity At Week 24 |
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating. |
Baseline, Week 24 |
|
| Secondary |
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For NMPP At Week 24 |
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating. |
Week 24 |
|
| Secondary |
Change From Baseline In PGA For Pain Severity At Week 24 |
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities. |
Baseline, Week 24 |
|
| Secondary |
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Pain Severity At Week 24 |
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities. |
Week 24 |
|
| Secondary |
Change From Baseline In PGA For Function At Week 24 |
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities. |
Baseline, Week 24 |
|
| Secondary |
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Function At Week 24 |
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities. |
Week 24 |
|
| Secondary |
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 24 |
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. |
Week 24 |
|
| Secondary |
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 24 |
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. |
Week 24 |
|
| Secondary |
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 24 |
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during sexual intercourse. |
Week 24 |
|
| Secondary |
Change From Baseline In The Non-Pain Of The EHP-30 Domains At Week 24 |
Assessed using the non-pain domains (Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image) of the EHP-30 questionnaire. |
Baseline, Week 24 |
|
| Secondary |
Change From Baseline In The EHP-30 Scale Total Score At Week 24 |
Assessed using the total score of the EHP-30 questionnaire. |
Baseline, Week 24 |
|
| Secondary |
Change From Baseline In The EHP Work Domain Score At Week 24 |
The EHP Work domain is a 5-item questionnaire that assesses impact of pain on ability to work. |
Baseline, Week 24 |
|
| Secondary |
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 |
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life. |
Baseline, Week 24 |
|
| Secondary |
Change From Baseline To Week 24 In EQ-5D-5L Visual Analogue Scale Score At Week 24 |
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life. |
Baseline, Week 24 |
|
| Secondary |
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA |
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. |
Week 24 or EOT |
|
| Secondary |
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA |
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. |
Week 24 or EOT |
|
| Secondary |
Change From Baseline In The EHP-30 Pain Score At Week 24 For Relugolix Plus Delayed E2/NETA |
Assessed using the Pain Domain of the EHP-30 questionnaire. |
Baseline, Week 24 |
|
| Secondary |
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 |
Assessed using the pain domain of the EHP-30 questionnaire. |
Baseline to Week 24 |
|
| Secondary |
Percentage Change From Baseline In Bone Mineral Density At The Lumbar Spine (L1-L4) At Week 12 |
Assessed by dual-energy X-ray absorptiometry (DXA) scan. |
Baseline, Week 12 |
|
| Secondary |
Percentage Change From Baseline In Bone Mineral Density At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 24 |
Assessed by DXA scan. |
Baseline, Week 24 |
|
| Secondary |
Percentage Of Participants Experiencing Vasomotor Symptoms At Week 12 Between Group A And B |
|
Week 12 |
|
| Secondary |
Change From Baseline In Serum Concentrations Of Luteinizing Hormone, Follicle Stimulating Hormone, Estradiol, And Progesterone |
Blood samples will be collected from participants for hormonal measurements. |
Baseline, Week 24 |
|
| Secondary |
Pre-dose Relugolix Plasma Concentrations |
Blood samples will be collected from participants for relugolix measurements. |
Week 4 |
|
| Secondary |
Endometrial Biopsy At Week 24 |
Primary diagnosis of endometrial biopsy assessment by pathologist. |
Week 24 |
|
