SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
NCT ID: NCT03654274
Last Updated: 2023-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
802 participants
INTERVENTIONAL
2018-05-22
2023-01-31
Brief Summary
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Detailed Description
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Approximately 800 women with endometriosis-associated pain will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 104 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose E2/NETA.
Baseline procedures for this extension study will be performed on the same day as the Week 24 Visit of the parent study. This visit, referred to as the "Week 24/Baseline Visit, will be defined as the date of completion of the last Week 24 procedure in the parent study. Participants will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the participant is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3103 will define enrollment into this study. Study participants will then take the open-label study treatment orally, once daily for 80 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Relugolix plus E2/NETA
Relugolix co-administered with E2/NETA for 80 weeks.
Relugolix
Relugolix 40-mg tablet administered orally once daily
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Interventions
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Relugolix
Relugolix 40-mg tablet administered orally once daily
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
Exclusion Criteria
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 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.
4. Has any contraindication to treatment with low-dose E2 and NETA, including:
1. Known, suspected, or history of breast cancer;
2. Known or suspected estrogen-dependent neoplasia;
3. Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit;
4. History of or active arterial thromboembolic disease, including stroke and myocardial infarction;
5. Known anaphylactic reaction or angioedema or hypersensitivity to E2 or NETA;
6. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden;
7. Migraine with aura;
8. History of porphyria.
5. 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):
1. Alanine aminotransferase or aspartate aminotransferase \> 2.0 times the upper limit of normal (ULN); or
2. Bilirubin (total bilirubin) \> 1.5 x ULN (or \> 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
18 Years
51 Years
FEMALE
No
Sponsors
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Myovant Sciences GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Myovant Medical Monitor
Role: STUDY_DIRECTOR
Myovant Sciences
Locations
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Andalusia
Andalusia, Alabama, United States
Scottsdale
Scottsdale, Arizona, United States
Tucson
Tucson, Arizona, United States
Tuscon
Tucson, Arizona, United States
Canoga Park
Canoga Park, California, United States
Los Angeles
Los Angeles, California, United States
San Diego
San Diego, California, United States
Greenwood Village
Greenwood Village, Colorado, United States
Washington
Washington D.C., District of Columbia, United States
Aventura
Aventura, Florida, United States
Fort Myers
Fort Myers, Florida, United States
Hialeah
Hialeah, Florida, United States
Hialeah
Hialeah, Florida, United States
Margate
Margate, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Sarasota
Sarasota, Florida, United States
Tampa
Tampa, Florida, United States
Atlanta
Atlanta, Georgia, United States
Atlanta
Atlanta, Georgia, United States
Augusta
Augusta, Georgia, United States
Norcross
Norcross, Georgia, United States
Idaho Falls
Idaho Falls, Idaho, United States
Oakbrook
Oakbrook Terrace, Illinois, United States
Park Ridge
Park Ridge, Illinois, United States
Shawnee
Shawnee Mission, Kansas, United States
Marrero
Marrero, Louisiana, United States
Towson
Towson, Maryland, United States
Saginaw
Saginaw, Michigan, United States
Jefferson City
Jefferson City, Missouri, United States
St. Louis
St Louis, Missouri, United States
Omaha
Omaha, Nebraska, United States
Las Vegas
Las Vegas, Nevada, United States
Durham
Durham, North Carolina, United States
New Bern
New Bern, North Carolina, United States
Winston Salem
Winston-Salem, North Carolina, United States
Akron
Akron, Ohio, United States
Columbus
Columbus, Ohio, United States
Englewood
Englewood, Ohio, United States
Hershey
Hershey, Pennsylvania, United States
Columbia
Columbia, South Carolina, United States
Chattanooga
Chattanooga, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Beaumont
Beaumont, Texas, United States
Corpus Christi
Corpus Christi, Texas, United States
Dallas
Dallas, Texas, United States
Fort Worth
Fort Worth, Texas, United States
Houston
Houston, Texas, United States
Houston
Houston, Texas, United States
Irving
Irving, Texas, United States
San Antonio
San Antonio, Texas, United States
Sugar Land
Sugar Land, Texas, United States
Webster
Webster, Texas, United States
Salt Lake City
Salt Lake City, Utah, United States
Salt Lake City
Salt Lake City, Utah, United States
Salt Lake City
Salt Lake City, Utah, United States
Norfolk
Norfolk, Virginia, United States
Richmond
Richmond, Virginia, United States
Virginia Beach
Virginia Beach, Virginia, United States
Seattle
Seattle, Washington, United States
Ciudad de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires, Argentina
San Isidro
San Isidro, Buenos Aires, Argentina
Rosario
Rosario, Santa Fe Province, Argentina
Cordoba
Córdoba, , Argentina
Sydney
Sydney, New South Wales, Australia
Wollongong
Wollongong, NS, Australia
Taringa
Taringa, Queensland, Australia
Adelaide
Adelaide, South Australia, Australia
Nedlands
Nedlands, Western Australia, Australia
Leuven
Leuven, Flemish Brabant, Belgium
La Louvière
La Louvière, Hainaut, Belgium
Gent
Ghent, Oost-vlaanderen, Belgium
Brussels
Brussels, , Belgium
Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil
Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre
Porto Alegre, São Paulo, Brazil
São Bernardo do Campo
São Bernardo do Campo, São Paulo, Brazil
São Paulo
São Paulo, São Paulo, Brazil
Sao Paulo
São Paulo, São Paulo, Brazil
São Paulo
São Paulo, São Paulo, Brazil
Sao Paulo
São Paulo, , Brazil
Sofia
Sofia, Sofia, Bulgaria
Sofia
Sofia, Sofia, Bulgaria
Sofia
Sofia, Sofia, Bulgaria
Sofia
Sofia, Sofia, Bulgaria
Blagoevgrad
Blagoevgrad, , Bulgaria
Pleven
Pleven, , Bulgaria
Stara Zagora
Stara Zagora, , Bulgaria
Varna
Varna, , Bulgaria
Red Deer
Red Deer, Alberta, Canada
Waterloo
Waterloo, Ontario, Canada
Victoriaville
Victoriaville, Quebec, Canada
Santiago
Santiago, , Chile
Santiago
Santiago, , Chile
Santiago
Santiago, , Chile
Tábor
Tábor, Jihormoravsky Kraj, Czechia
Písek
Písek, Jihočeský kraj, Czechia
Vodňany
Vodňany, Jihočeský kraj, Czechia
Náchod
Náchod, Královéhradecký kraj, Czechia
Praha 10
Prague, Prague, Czechia
Praha 2
Prague, Prague, Czechia
České Budějovice
České Budějovice, , Czechia
Olomouc
Olomouc, , Czechia
Praha 8 - Libeň
Praha 8 - Libeň, , Czechia
Kuopio
Kuopio, Eastern Finland, Finland
Helsinki
Helsinki, Southern Finland, Finland
Oulu
Oulu, , Finland
Tbilisi
Tbilisi, , Georgia
Pécs
Pécs, Baranya, Hungary
Békéscsaba
Békéscsaba, Bekes County, Hungary
Gyula
Gyula, Bekes County, Hungary
Kecskemét
Kecskemét, Bács-Kiskun county, Hungary
Szeged
Szeged, Csongrád megye, Hungary
Debrecen
Debrecen, Hajdú-Bihar, Hungary
Debrecen
Debrecen, Hajdú-Bihar, Hungary
Debrecen
Debrecen, Hajdú-Bihar, Hungary
Nyíregyháza
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Monserrato
Monserrato, Cagliari, Italy
Catanzaro
Catanzaro, , Italy
Napoli
Napoli, , Italy
Pavia
Pavia, , Italy
Roma
Roma, , Italy
Remuera
Remuera, Auckland, New Zealand
Palmerston North
Palmerston North, Manawatu-Wanganui, New Zealand
Christchurch
Christchurch, , New Zealand
Skórzewo
Skórzewo, Greater Poland Voivodeship, Poland
Lublin
Lublin, Lublin Voivodeship, Poland
Lublin
Lublin, Lublin Voivodeship, Poland
Lublin
Lublin, Lublin Voivodeship, Poland
Lublin
Lublin, Lublin Voivodeship, Poland
Warszawa
Warsaw, Masovian Voivodeship, Poland
Warszawa
Warsaw, Masovian Voivodeship, Poland
Warszawa
Warsaw, Masovian Voivodeship, Poland
Białystok
Bialystok, Podlaskie Voivodeship, Poland
Katowice
Katowice, Silesian Voivodeship, Poland
Katowice
Katowice, Silesian Voivodeship, Poland
Szczecin
Szczecin, West Pomeranian Voivodeship, Poland
Łódź
Lodz, Łódź Voivodeship, Poland
Almada
Almada, Lisbon District, Portugal
Coimbra
Coimbra, , Portugal
Covilhã
Covilha, , Portugal
Porto
Porto, , Portugal
Brasov
Brasov, , Romania
Bucuresti
Bucharest, , Romania
Bucuresti
Bucharest, , Romania
Bucuresti
Bucharest, , Romania
București
Bucharest, , Romania
Port Elizabeth
Port Elizabeth, Eastern Cape, South Africa
Centurion
Centurion, Gauteng, South Africa
Roodepoort
Roodepoort, Gauteng, South Africa
Durban
Durban, KwaZulu-Natal, South Africa
Cape Town
Cape Town, Western Cape, South Africa
Madrid
Madrid, , Spain
Valencia
Valencia, , Spain
Kyiv
Kyiv, Kiev City, Ukraine
Kyiv
Kyiv, Kiev City, Ukraine
Kyiv
Kyiv, Kyiv City, Ukraine
Chernivtsi
Chernivtsi, , Ukraine
Ivano-Frankivsk
Ivano-Frankivsk, , Ukraine
Kharkiv
Kharkiv, , Ukraine
Kiev
Kiev, , Ukraine
Kiev
Kiev, , Ukraine
Kyiv
Kyiv, , Ukraine
Zaporizhzhya
Zaporizhzhya, , Ukraine
Zaporizhzhya
Zaporizhzhya, , Ukraine
Zaporizhzhya
Zaporizhzhya, , Ukraine
Zaporizhzhya
Zaporizhzhya, , Ukraine
Countries
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References
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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.
Becker 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004066-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MVT-601-3103
Identifier Type: -
Identifier Source: org_study_id
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