SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain
2 other identifiers
interventional
802
20 countries
169
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2018
Longer than P75 for phase_3
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2018
CompletedFirst Submitted
Initial submission to the registry
August 29, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedResults Posted
Study results publicly available
July 20, 2023
CompletedAugust 8, 2023
August 1, 2023
3.6 years
August 29, 2018
March 3, 2023
August 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 52 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Week 52
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 52 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Week 52
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 104 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Week 104
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 104 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Week 104
Secondary Outcomes (37)
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52
Week 52
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104
Week 104
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
Week 52
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
Week 104
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52
Week 52
- +32 more secondary outcomes
Study Arms (1)
Relugolix plus E2/NETA
EXPERIMENTALRelugolix co-administered with E2/NETA for 80 weeks.
Interventions
Relugolix 40-mg tablet administered orally once daily
Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 or has a ≥ 7% decrease in bone mineral density from the parent study Baseline at lumbar spine, total hip, or femoral neck based on the parent study Week 24 DXA assessment of bone mineral density.
- Has any contraindication to treatment with low-dose E2 and NETA, including:
- Known, suspected, or history of breast cancer;
- Known or suspected estrogen-dependent neoplasia;
- Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit;
- History of or active arterial thromboembolic disease, including stroke and myocardial infarction;
- Known anaphylactic reaction or angioedema or hypersensitivity to E2 or NETA;
- Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden;
- Migraine with aura;
- History of porphyria.
- Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or, if available, any subsequent visit in one of the parent studies (MVT-601-3101 or MVT-601-3102):
- Alanine aminotransferase or aspartate aminotransferase \> 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (169)
Andalusia
Andalusia, Alabama, 36420, United States
Scottsdale
Scottsdale, Arizona, 85251, United States
Tucson
Tucson, Arizona, 85704, United States
Tuscon
Tucson, Arizona, 85712, United States
Canoga Park
Canoga Park, California, 91303, United States
Los Angeles
Los Angeles, California, 70433, United States
San Diego
San Diego, California, 92111, United States
Greenwood Village
Greenwood Village, Colorado, 80111, United States
Washington
Washington D.C., District of Columbia, 20036, United States
Aventura
Aventura, Florida, 33180, United States
Fort Myers
Fort Myers, Florida, 33912, United States
Hialeah
Hialeah, Florida, 33012, United States
Hialeah
Hialeah, Florida, 33016, United States
Margate
Margate, Florida, 33063, United States
Miami
Miami, Florida, 33126, United States
Miami
Miami, Florida, 33155, United States
Sarasota
Sarasota, Florida, 34239, United States
Tampa
Tampa, Florida, 33606, United States
Atlanta
Atlanta, Georgia, 30312, United States
Atlanta
Atlanta, Georgia, 30363, United States
Augusta
Augusta, Georgia, 30909, United States
Norcross
Norcross, Georgia, 30093, United States
Idaho Falls
Idaho Falls, Idaho, 83404, United States
Oakbrook
Oakbrook Terrace, Illinois, 60523, United States
Park Ridge
Park Ridge, Illinois, 60068, United States
Shawnee
Shawnee Mission, Kansas, 66218, United States
Marrero
Marrero, Louisiana, 70072, United States
Towson
Towson, Maryland, 21204, United States
Saginaw
Saginaw, Michigan, 48602, United States
Jefferson City
Jefferson City, Missouri, 65109, United States
St. Louis
St Louis, Missouri, 63141, United States
Omaha
Omaha, Nebraska, 68130, United States
Las Vegas
Las Vegas, Nevada, 89113, United States
Durham
Durham, North Carolina, 27713, United States
New Bern
New Bern, North Carolina, 28562, United States
Winston Salem
Winston-Salem, North Carolina, 27103, United States
Akron
Akron, Ohio, 44313, United States
Columbus
Columbus, Ohio, 43235, United States
Englewood
Englewood, Ohio, 45322, United States
Hershey
Hershey, Pennsylvania, 17033-0850, United States
Columbia
Columbia, South Carolina, 29201, United States
Chattanooga
Chattanooga, Tennessee, 37404, United States
Memphis
Memphis, Tennessee, 38120, United States
Beaumont
Beaumont, Texas, 77702, United States
Corpus Christi
Corpus Christi, Texas, 78412, United States
Dallas
Dallas, Texas, 75231, United States
Fort Worth
Fort Worth, Texas, 76104, United States
Houston
Houston, Texas, 77030, United States
Houston
Houston, Texas, 77054, United States
Irving
Irving, Texas, 75062, United States
San Antonio
San Antonio, Texas, 78258, United States
Sugar Land
Sugar Land, Texas, 77479, United States
Webster
Webster, Texas, 77598, United States
Salt Lake City
Salt Lake City, Utah, 84102, United States
Salt Lake City
Salt Lake City, Utah, 84107, United States
Salt Lake City
Salt Lake City, Utah, 84124, United States
Norfolk
Norfolk, Virginia, 23507, United States
Richmond
Richmond, Virginia, 23235, United States
Virginia Beach
Virginia Beach, Virginia, 23502, United States
Seattle
Seattle, Washington, 98105, United States
Ciudad de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires, C1128AAF, Argentina
San Isidro
San Isidro, Buenos Aires, B1642CKL, Argentina
Rosario
Rosario, Santa Fe Province, S2000PRB, Argentina
Cordoba
Córdoba, X5000JHQ, Argentina
Sydney
Sydney, New South Wales, 2000, Australia
Wollongong
Wollongong, NS, 2522, Australia
Taringa
Taringa, Queensland, 4068, Australia
Adelaide
Adelaide, South Australia, 5000, Australia
Nedlands
Nedlands, Western Australia, 6009, Australia
Leuven
Leuven, Flemish Brabant, 3000, Belgium
La Louvière
La Louvière, Hainaut, 7100, Belgium
Gent
Ghent, Oost-vlaanderen, 9000, Belgium
Brussels
Brussels, 1070, Belgium
Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Porto Alegre
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Porto Alegre
Porto Alegre, Rio Grande do Sul, 90510-040, Brazil
Porto Alegre
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Porto Alegre
Porto Alegre, São Paulo, 90035-903, Brazil
São Bernardo do Campo
São Bernardo do Campo, São Paulo, 09715-090, Brazil
São Paulo
São Paulo, São Paulo, 04023-062, Brazil
Sao Paulo
São Paulo, São Paulo, 04266-010, Brazil
São Paulo
São Paulo, São Paulo, 04708-001, Brazil
Sao Paulo
São Paulo, 01317-000, Brazil
Sofia
Sofia, Sofia, 1233, Bulgaria
Sofia
Sofia, Sofia, 1336, Bulgaria
Sofia
Sofia, Sofia, 1431, Bulgaria
Sofia
Sofia, Sofia, 1504, Bulgaria
Blagoevgrad
Blagoevgrad, 2700, Bulgaria
Pleven
Pleven, 5809, Bulgaria
Stara Zagora
Stara Zagora, 6003, Bulgaria
Varna
Varna, 9002, Bulgaria
Red Deer
Red Deer, Alberta, T4N 6V7, Canada
Waterloo
Waterloo, Ontario, N2J1C4, Canada
Victoriaville
Victoriaville, Quebec, G6P 6P6, Canada
Santiago
Santiago, 7510186, Chile
Santiago
Santiago, 8320143, Chile
Santiago
Santiago, 8880465, Chile
Tábor
Tábor, Jihormoravsky Kraj, 390 03, Czechia
Písek
Písek, Jihočeský kraj, 397 01, Czechia
Vodňany
Vodňany, Jihočeský kraj, 389 01, Czechia
Náchod
Náchod, Královéhradecký kraj, 547 01, Czechia
Praha 10
Prague, Prague, 100 34, Czechia
Praha 2
Prague, Prague, 128 08, Czechia
České Budějovice
České Budějovice, 370 01, Czechia
Olomouc
Olomouc, 772 00, Czechia
Praha 8 - Libeň
Praha 8 - Libeň, 180 81, Czechia
Kuopio
Kuopio, Eastern Finland, 70100, Finland
Helsinki
Helsinki, Southern Finland, 00260, Finland
Oulu
Oulu, 90100, Finland
Tbilisi
Tbilisi, 0159, Georgia
Pécs
Pécs, Baranya, 7624, Hungary
Békéscsaba
Békéscsaba, Bekes County, 5600, Hungary
Gyula
Gyula, Bekes County, 5700, Hungary
Kecskemét
Kecskemét, Bács-Kiskun county, 6000, Hungary
Szeged
Szeged, Csongrád megye, 6725, Hungary
Debrecen
Debrecen, Hajdú-Bihar, 4024, Hungary
Debrecen
Debrecen, Hajdú-Bihar, 4025, Hungary
Debrecen
Debrecen, Hajdú-Bihar, 4032, Hungary
Nyíregyháza
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Monserrato
Monserrato, Cagliari, 9042, Italy
Catanzaro
Catanzaro, 88100, Italy
Napoli
Napoli, 80131, Italy
Pavia
Pavia, 27100, Italy
Roma
Roma, 00168, Italy
Remuera
Remuera, Auckland, 1050, New Zealand
Palmerston North
Palmerston North, Manawatu-Wanganui, 4442, New Zealand
Christchurch
Christchurch, 8013, New Zealand
Skórzewo
Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Lublin
Lublin, Lublin Voivodeship, 20-064, Poland
Lublin
Lublin, Lublin Voivodeship, 20-093, Poland
Lublin
Lublin, Lublin Voivodeship, 20-632, Poland
Lublin
Lublin, Lublin Voivodeship, 20-880, Poland
Warszawa
Warsaw, Masovian Voivodeship, 02-066, Poland
Warszawa
Warsaw, Masovian Voivodeship, 02-201, Poland
Warszawa
Warsaw, Masovian Voivodeship, 02-929, Poland
Białystok
Bialystok, Podlaskie Voivodeship, 15-224, Poland
Katowice
Katowice, Silesian Voivodeship, 40-081, Poland
Katowice
Katowice, Silesian Voivodeship, 40-301, Poland
Szczecin
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Łódź
Lodz, Łódź Voivodeship, 90-602, Poland
Almada
Almada, Lisbon District, 2805-267, Portugal
Coimbra
Coimbra, 3000-075, Portugal
Covilhã
Covilha, 6200-251, Portugal
Porto
Porto, 4099-001, Portugal
Brasov
Brasov, 500091, Romania
Bucuresti
Bucharest, 012071, Romania
Bucuresti
Bucharest, 022441, Romania
Bucuresti
Bucharest, 024091, Romania
București
Bucharest, 20475, Romania
Port Elizabeth
Port Elizabeth, Eastern Cape, 6001, South Africa
Centurion
Centurion, Gauteng, 0157, South Africa
Roodepoort
Roodepoort, Gauteng, 1724, South Africa
Durban
Durban, KwaZulu-Natal, 4126, South Africa
Cape Town
Cape Town, Western Cape, 7405, South Africa
Madrid
Madrid, 28041, Spain
Valencia
Valencia, 46010, Spain
Kyiv
Kyiv, Kiev City, 2232, Ukraine
Kyiv
Kyiv, Kiev City, 4050, Ukraine
Kyiv
Kyiv, Kyiv City, 1034, Ukraine
Chernivtsi
Chernivtsi, 58001, Ukraine
Ivano-Frankivsk
Ivano-Frankivsk, 76018, Ukraine
Kharkiv
Kharkiv, 61052, Ukraine
Kiev
Kiev, 3148, Ukraine
Kiev
Kiev, 4112, Ukraine
Kyiv
Kyiv, 04053, Ukraine
Zaporizhzhya
Zaporizhzhya, 69063, Ukraine
Zaporizhzhya
Zaporizhzhya, 69065, Ukraine
Zaporizhzhya
Zaporizhzhya, 69068, Ukraine
Zaporizhzhya
Zaporizhzhya, 69071, Ukraine
Related Publications (2)
As-Sanie S, Abrao MS, Reznichenko G, Wilk K, Zhong Y, Perry J, Hunsche E, Soulban G, Becker CM. Impact of relugolix combination therapy on functioning and quality of life in women with endometriosis-associated pain. Fertil Steril. 2024 Oct;122(4):687-695. doi: 10.1016/j.fertnstert.2024.06.009. Epub 2024 Jun 19.
PMID: 38906210DERIVEDBecker CM, Johnson NP, As-Sanie S, Arjona Ferreira JC, Abrao MS, Wilk K, Imm SJ, Mathur V, Perry JS, Wagman RB, Giudice LC. Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study. Hum Reprod. 2024 Mar 1;39(3):526-537. doi: 10.1093/humrep/dead263.
PMID: 38243752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials at Myovant
- Organization
- Myovant Sciences GmbH
Study Officials
- STUDY DIRECTOR
Myovant Medical Monitor
Myovant Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2018
First Posted
August 31, 2018
Study Start
May 22, 2018
Primary Completion
December 16, 2021
Study Completion
January 31, 2023
Last Updated
August 8, 2023
Results First Posted
July 20, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share