SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
NCT ID: NCT03204331
Last Updated: 2021-06-28
Study Results
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Basic Information
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COMPLETED
PHASE3
623 participants
INTERVENTIONAL
2017-11-01
2021-05-31
Brief Summary
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Detailed Description
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Approximately 600 women with endometriosis-associated pain were enrolled and randomized 1:1:1 to Group A - relugolix plus low-dose hormonal add-back therapy, Group B - relugolix monotherapy for 12 weeks followed by co-administration with low-dose hormonal add-back therapy, or Group C - placebo (N = 200 per group).
Eligible participants were randomized on Baseline Day 1 to Treatment Group A, B, or C, in the double-blind period.
Eligible participants, including those randomized to placebo, were offered the opportunity to enroll in an 80-week open label extension study where participants received relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a Follow-Up visit approximately 30 days after the participant's last dose of study drug.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Relugolix plus E2/NETA (Group A)
Relugolix co-administered with E2/NETA for 24 weeks.
Relugolix
Relugolix 40-mg tablet administered orally once daily.
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
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.
Relugolix
Relugolix 40-mg tablet administered orally once daily.
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
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.
Placebo (Group C)
Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.
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.
Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
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)/NETA (0.5 mg) administered orally once daily.
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.
Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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 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.
18 Years
50 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
Washington DC
Washington D.C., District of Columbia, United States
Aventura
Aventura, Florida, United States
Deland
DeLand, Florida, United States
Hialeah
Hialeah, Florida, United States
Hialeah
Hialeah, Florida, United States
Margate
Margate, Florida, United States
Miami
Miami, Florida, United States
Port St. Lucie
Port Saint Lucie, Florida, United States
Tampa
Tampa, Florida, United States
Atlanta
Atlanta, Georgia, United States
Idaho Falls
Idaho Falls, Idaho, United States
Park Ridge
Park Ridge, Illinois, United States
Lafayette
Lafayette, Indiana, United States
Covington
Covington, Louisiana, United States
Marrero
Marrero, Louisiana, United States
Towson
Towson, Maryland, United States
Saginaw
Saginaw, Michigan, United States
St. Louis
St Louis, Missouri, United States
Omaha
Omaha, Nebraska, United States
Albuquerque
Albuquerque, New Mexico, United States
New York
New York, New York, United States
New Bern
New Bern, North Carolina, United States
Akron
Akron, Ohio, United States
Columbus
Columbus, Ohio, United States
Columbus
Columbus, Ohio, United States
Franklin
Franklin, Ohio, United States
Columbia
Columbia, South Carolina, United States
Spartanburg
Spartanburg, South Carolina, United States
Chattanooga
Chattanooga, 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
Irving
Irving, Texas, United States
San Antonio
San Antonio, Texas, United States
Sugar Land
Sugar Land, Texas, United States
Pleasant Grove
Pleasant Grove, Utah, United States
Salt Lake City
Salt Lake City, Utah, United States
Virginia Beach
Virginia Beach, Virginia, United States
Sydney
Sydney, New South Wales, Australia
Wollongong
Wollongong, New South Wales, Australia
Sherwood
Sherwood, Queensland, Australia
Adelaide
Adelaide, South Australia, Australia
Nedlands
Nedlands, Western Australia, Australia
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
São Paulo
São Paulo, São Paulo, Brazil
São Paulo
São Paulo, São Paulo, Brazil
São Paulo
São Paulo, São Paulo, Brazil
São Paulo
São Paulo, São Paulo, Brazil
Santiago
Santiago, , Chile
Santiago
Santiago, , Chile
Santiago
Santiago, , Chile
Santiago
Santiago, , Chile
Tábor
Tábor, Jihormoravsky KRAJ, Czechia
Písek
Písek, Jihočeský kraj, Czechia
Praha 2
Prague, Prague, Czechia
Ceské Budejovice
České Budějovice, , Czechia
Tbilisi
Tbilisi, Borjomi, Georgia
Monserrato
Monserrato, Cagliari, Italy
Catanzaro
Catanzaro, , Italy
Napoli
Napoli, , Italy
Pavia
Pavia, , Italy
Roma
Roma, , Italy
Birkenhead
Birkenhead, Auckland, New Zealand
Remuera
Remuera, Auckland, New Zealand
Tauranga
Tauranga, Bay of Plenty, New Zealand
Palmerston North
Palmerston North, Manawatu-Wanganui, New Zealand
Christchurch
Christchurch, , New Zealand
Poznan
Poznan, Greater Poland 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
Bialystok
Bialystok, Podlaskie Voivodeship, Poland
Białystok
Bialystok, Podlaskie Voivodeship, Poland
Katowice
Katowice, Silesian Voivodeship, Poland
Lodz
Lodz, Łódź Voivodeship, Poland
București
Bucharest, București, Romania
Brasov
Brasov, , Romania
Bucuresti
Bucharest, , Romania
Bucuresti
Bucharest, , Romania
Malmö
Malmo, Skåne County, Sweden
Countries
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References
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Giudice LC, As-Sanie S, Arjona Ferreira JC, Becker CM, Abrao MS, Lessey BA, Dynowski K, Wilk K, Li Y, Mathur V, Wagman RB, Johnson NP. A Plain Language Summary to learn about relugolix combination therapy for the treatment of pain associated with endometriosis. Pain Manag. 2023 Nov;13(11):631-640. doi: 10.2217/pmt-2023-0052. Epub 2023 Nov 20.
Hunsche E, Gauthier M, Witherspoon B, Rakov V, Agarwal SK. Endometriosis Symptoms and Their Impacts on the Daily Lives of US Women: Results from an Interview Study. Int J Womens Health. 2023 Jun 1;15:893-904. doi: 10.2147/IJWH.S409733. eCollection 2023.
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.
Other Identifiers
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2017-001632-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MVT-601-3102
Identifier Type: -
Identifier Source: org_study_id
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