Phase 3
N=802
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT03654274 ↗Enrolled (actual)
802
Serious AEs
5.5%
Results posted
Jul 2023
Primary outcome: Primary: Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 — 84.8; 82.2; 75.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Relugolix (Drug); Estradiol/norethindrone acetate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Myovant Sciences GmbH
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 |
84.8; 82.2; 75.6 | — |
| PRIMARY Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52 |
73.6; 70.4; 68.0 | — |
| PRIMARY Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104 |
84.8; 83.0; 80.4 | — |
| PRIMARY Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104 |
75.8; 71.7; 73.1 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52 |
-37.7; -36.1; -35.1 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104 |
-41.3; -38.9; -37.7 | — |
| SECONDARY Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 52 |
83.6; 81.2; 79.5 | — |
| SECONDARY Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 104 |
88.6; 85.4; 86.1 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52 |
-5.9; -5.7; -5.3 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104 |
-5.9; -5.7; -5.6 | — |
| SECONDARY Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52 |
89.1; 87.1; 83.0 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52 |
-3.6; -3.4; -3.4 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104 |
-4.0; -3.5; -3.8 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52 |
-3.9; -3.6; -3.6 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104 |
-4.2; -3.9; -4.0 | — |
| SECONDARY Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104 |
91.0; 88.3; 90.5 | — |
| SECONDARY Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104 |
75.1; 76.5; 76.0 | — |
| SECONDARY Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 52 |
85.5; 86.1; 79.1 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52 |
-3.3; -3.0; -3.0 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104 |
-3.5; -2.9; -3.4 | — |
| SECONDARY Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 52 |
61.0; 61.9; 60.0 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52 |
-0.9; -0.9; -0.8 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104 |
-1.0; -0.9; -1.0 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52 |
-1.3; -1.2; -1.2 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 104 |
-1.4; -1.4; -1.3 | — |
| SECONDARY Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 |
81.5; 69.9; 72.6; 14.7; 26.2; 23.0 | — |
| SECONDARY Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 |
85.5; 82.2; 80.4; 13.8; 15.8; 16.7 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52 |
-1.6; -1.6; -1.6 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104 |
-1.9; -1.9; -1.8 | — |
| SECONDARY Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 |
88.9; 86.9; 86.1; 8.1; 12.6; 10.0 | — |
| SECONDARY Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 |
92.7; 92.0; 91.2; 6.7; 7.3; 8.8 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 |
-43.7; -40.1; -39.5; -26.7; -24.4; -23.7 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 |
-47.5; -43.7; -41.9; -30.7; -26.5; -25.6 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52 |
-1.3; -1.3; -1.2 | — |
| SECONDARY Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104 |
-1.3; -1.3; -1.2 | — |
| SECONDARY Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52 |
-1.0; -1.0; -1.0 | — |
| SECONDARY Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104 |
-1.2; -1.1; -1.1 | — |
| SECONDARY Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 |
-0.69; -1.09; -0.09; -0.21; -0.84; 0.06 | — |
| SECONDARY Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 |
-0.45; -0.56; -0.09; 0.24; -0.44; -0.05 | — |
| SECONDARY Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52 |
-55.22; -77.76; -62.07 | — |
| SECONDARY Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104 |
-51.72; -74.68; -64.39 | — |
Summary
The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).
Eligibility Criteria
Key Inclusion Criteria
- Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102.
- Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame.
- Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
Key Exclusion Criteria
- Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
- 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.
- Has a Z-score 2.0 times the upper limit of normal (ULN); or
- Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
Data sourced from ClinicalTrials.gov (NCT03654274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.