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Endometriosis Related PainPhase 3NCT03204331

SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

A Phase 3 study testing Relugolix and Estradiol/norethindrone acetate in people with Endometriosis Related Pain, run by Myovant Sciences GmbH at 91 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Endometriosis Related Pain
What is being tested?
Relugolix and Estradiol/norethindrone acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
623 participants
Where
91 sitesin 11 countries
Study dates
1 Nov 2017to 31 May 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form.
  • Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
  • 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.
  • 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
  • Mean NMPP NRS score ≥ 2.5, or
  • Mean NMPP NRS score ≥ 1.25 and NMPP NRS score ≥ 5.0 on ≥ 4 days.

Who cannot join

  • Has a history of chronic pelvic pain that is not caused by endometriosis.
  • 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 had surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit.
  • Has a history of or currently has osteoporosis or other metabolic bone disease.
  • Has a clinically significant gynecologic condition, other than endometriosis, identified during Screening or Run-In period transvaginal ultrasound or endometrial biopsy.

Trial locations and contacts

91 sites in 11 countries.

91 sites in 11 countries

United States41 sites

  • Akron

    Akron, Ohio, 44313

  • Albuquerque

    Albuquerque, New Mexico, 87102

  • Andalusia

    Andalusia, Alabama, 36420

  • Atlanta

    Atlanta, Georgia, 30312

  • Aventura

    Aventura, Florida, 33180

  • Beaumont

    Beaumont, Texas, 77702

  • Chattanooga

    Chattanooga, Tennessee, 37404

  • Columbia

    Columbia, South Carolina, 29201

  • Columbus

    Columbus, Ohio, 43231

  • Columbus

    Columbus, Ohio, 43235

  • Corpus Christi

    Corpus Christi, Texas, 78412

  • Covington

    Covington, Louisiana, 70433

  • Dallas

    Dallas, Texas, 75231

  • Deland

    DeLand, Florida, 32720

  • Fort Worth

    Fort Worth, Texas, 76104

  • Franklin

    Franklin, Ohio, 45005

  • Hialeah

    Hialeah, Florida, 33012

  • Hialeah

    Hialeah, Florida, 33016

  • Houston

    Houston, Texas, 77054

  • Idaho Falls

    Idaho Falls, Idaho, 83404

  • Irving

    Irving, Texas, 75062

  • Lafayette

    Lafayette, Indiana, 47905

  • Margate

    Margate, Florida, 33063

  • Marrero

    Marrero, Louisiana, 70072

  • Miami

    Miami, Florida, 33176

  • New Bern

    New Bern, North Carolina, 28562

  • New York

    New York, New York, 10038

  • Omaha

    Omaha, Nebraska, 68124

  • Park Ridge

    Park Ridge, Illinois, 60068

  • Pleasant Grove

    Pleasant Grove, Utah, 84062

  • Port St. Lucie

    Port Saint Lucie, Florida, 34952

  • Saginaw

    Saginaw, Michigan, 48602

  • Salt Lake City

    Salt Lake City, Utah, 84102

  • San Antonio

    San Antonio, Texas, 78258

  • Spartanburg

    Spartanburg, South Carolina, 29301

  • St. Louis

    St Louis, Missouri, 63141

  • Sugar Land

    Sugar Land, Texas, 77479

  • Tampa

    Tampa, Florida, 33606

  • Towson

    Towson, Maryland, 21204

  • Virginia Beach

    Virginia Beach, Virginia, 23502

  • Washington DC

    Washington D.C., District of Columbia, 20036

Other trials in United States

Brazil11 sites

  • Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90510-040

  • Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Porto Alegre

    Porto Alegre, São Paulo, 90035-903

  • São Bernardo do Campo

    São Bernardo do Campo, São Paulo, 09715-090

  • São Paulo

    São Paulo, São Paulo, 01317-000

  • São Paulo

    São Paulo, São Paulo, 01323-900

  • São Paulo

    São Paulo, São Paulo, 04023-062

  • São Paulo

    São Paulo, São Paulo, 04266-010

  • São Paulo

    São Paulo, São Paulo, 04708-001

Other trials in Brazil

Poland10 sites

  • Bialystok

    Bialystok, Podlaskie Voivodeship, 15-224

  • Białystok

    Bialystok, Podlaskie Voivodeship, 15-464

  • Katowice

    Katowice, Silesian Voivodeship, 40-301

  • Lodz

    Lodz, Łódź Voivodeship, 90-602

  • Lublin

    Lublin, Lublin Voivodeship, 20-064

  • Lublin

    Lublin, Lublin Voivodeship, 20-093

  • Poznan

    Poznan, Greater Poland Voivodeship, 60-185

  • Warszawa

    Warsaw, Masovian Voivodeship, 02-066

  • Warszawa

    Warsaw, Masovian Voivodeship, 02-201

  • Warszawa

    Warsaw, Masovian Voivodeship, 02-929

Other trials in Poland

Australia5 sites

  • Adelaide

    Adelaide, South Australia, 5000

  • Nedlands

    Nedlands, Western Australia, 6009

  • Sherwood

    Sherwood, Queensland, 4075

  • Sydney

    Sydney, New South Wales, 2000

  • Wollongong

    Wollongong, New South Wales, 2522

Other trials in Australia

Italy5 sites

  • Catanzaro

    Catanzaro, 88100

  • Monserrato

    Monserrato, Cagliari, 09042

  • Napoli

    Naples, 80131

  • Pavia

    Pavia, 27100

  • Roma

    Roma, 00168

Other trials in Italy

New Zealand5 sites

  • Birkenhead

    Birkenhead, Auckland, 0626

  • Christchurch

    Christchurch, 8013

  • Palmerston North

    Palmerston North, Manawatu-Wanganui, 4442

  • Remuera

    Remuera, Auckland, 1050

  • Tauranga

    Tauranga, Bay of Plenty, 3112

Other trials in New Zealand

Chile4 sites

  • Santiago

    Santiago, 7510186

  • Santiago

    Santiago, 8320165

  • Santiago

    Santiago, 8360160

  • Santiago

    Santiago, 8880465

Other trials in Chile

Czechia4 sites

  • Ceské Budejovice

    České Budějovice, 370 01

  • Písek

    Písek, South Bohemian Region, 39701

  • Praha 2

    Prague, Prague, 128 08

  • Tábor

    Tábor, Jihormoravsky KRAJ, 390 03

Other trials in Czechia

Romania4 sites

  • Brasov

    Brasov, 500091

  • București

    Bucharest, Bucharest, 20475

  • Bucuresti

    Bucharest, 012071

  • Bucuresti

    Bucharest, 022441

Other trials in Romania

Georgia1 site

  • Tbilisi

    Tbilisi, Borjomi, 0159

Other trials in Georgia

Sweden1 site

  • Malmö

    Malmö, Skåne County, 20502

Other trials in Sweden

About this study

Official title: SPIRIT 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain

The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

Read the detailed description

This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral, once-daily relugolix (40 mg) co-administered with either 12 or 24 weeks of low-dose E2 (1.0 mg) and NETA (0.5 mg), compared with placebo.

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.

Being tested
Relugolix, Estradiol/norethindrone acetate, Estradiol/norethindrone acetate placebo, Relugolix placebo
Keywords
Endometriosis, Pain, Dysmenorrhea
Medical subject headings
Endometriosis, Pain, Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelugolixDrug

    Also called TAK-385, MVT-601

    Relugolix 40-mg tablet administered orally once daily.

  • Estradiol/norethindrone acetateDrug

    Also called E2/NETA

    Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.

  • Estradiol/norethindrone acetate placeboDrug

    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 placeboDrug

    Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

Study groups in NCT03204331
Study groupRoleWhat they receive
Relugolix plus E2/NETA (Group A)ExperimentalRelugolix co-administered with E2/NETA for 24 weeks.
Receives: Drug: Relugolix; Drug: Estradiol/norethindrone acetate
Relugolix plus Delayed E2/NETA (Group B)ExperimentalRelugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
Receives: Drug: Relugolix; Drug: Estradiol/norethindrone acetate; Drug: Estradiol/norethindrone acetate placebo
Placebo (Group C)Placebo comparatorRelugolix placebo co-administered with E2/NETA placebo for 24 weeks.
Receives: Drug: Estradiol/norethindrone acetate placebo; Drug: Relugolix placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 24 or EOT

  2. 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.

    Measured: Week 24 or EOT

Secondary outcomes (43)

  1. 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.

    Measured: Baseline, Week 24

  2. 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.

    Measured: Baseline, Week 24 or EOT

  3. 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.

    Measured: Baseline, Week 24 or EOT

  4. 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.

    Measured: Baseline, Week 24 or EOT

  5. 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.

    Measured: Baseline, Week 24 or EOT

  6. 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.

    Measured: Week 24 or EOT

  7. 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.

    Measured: Baseline, Week 24 or EOT

  8. 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.

    Measured: Baseline to Week 24

  9. Dysmenorrhea Responder Rate By Month

    The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

    Measured: Baseline to Week 24

  10. NMPP Responder Rate By Month

    The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

    Measured: Baseline to Week 24

  11. Change In Dysmenorrhea NRS Score By Month

    Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.

    Measured: Baseline to Week 24

  12. Change In NMPP NRS Score By Month

    Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.

    Measured: Baseline to Week 24

  13. 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.

    Measured: Baseline to Week 24

  14. Change In Dyspareunia NRS Score By Month

    Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.

    Measured: Baseline to Week 24

  15. 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.

    Measured: Baseline, Week 24

  16. 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.

    Measured: Baseline, Week 24

  17. 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.

    Measured: Baseline, Week 24 or EOT

  18. 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.

    Measured: Baseline, Week 24 or EOT

  19. 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.

    Measured: Baseline, Week 24 or EOT

  20. 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.

    Measured: Baseline, Week 24

  21. 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.

    Measured: Week 24

  22. 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.

    Measured: Baseline, Week 24

  23. 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.

    Measured: Week 24

  24. 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.

    Measured: Baseline, Week 24

  25. 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.

    Measured: Week 24

  26. 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.

    Measured: Baseline, Week 24

  27. 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.

    Measured: Week 24

  28. 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.

    Measured: Week 24

  29. 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.

    Measured: Week 24

  30. 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.

    Measured: Week 24

  31. 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.

    Measured: Baseline, Week 24

  32. Change From Baseline In The EHP-30 Scale Total Score At Week 24

    Assessed using the total score of the EHP-30 questionnaire.

    Measured: Baseline, Week 24

  33. 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.

    Measured: Baseline, Week 24

  34. 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.

    Measured: Baseline, Week 24

  35. 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.

    Measured: Baseline, Week 24

  36. 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.

    Measured: Week 24 or EOT

  37. 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.

    Measured: Week 24 or EOT

  38. 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.

    Measured: Baseline, Week 24

  39. 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.

    Measured: Baseline to Week 24

  40. 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.

    Measured: Baseline, Week 12

  41. 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.

    Measured: Baseline, Week 24

  42. Percentage Of Participants Experiencing Vasomotor Symptoms At Week 12 Between Group A And B

    Measured: Week 12

  43. 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.

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study start1 Nov 2017
  3. Primary completion1 Apr 2020
  4. Study completion31 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03204331
Sponsor's protocol ID
MVT-601-3102
Other IDs
2017-001632-19, 2017
Status last verified
Jun 2021
First submitted
27 Jun 2017
Last updated
28 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37982388

  • 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.

    PubMed 37283994

  • 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.

    PubMed 35717987

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relugolix and Estradiol/norethindrone acetate in people with Endometriosis Related Pain, run by Myovant Sciences GmbH at 91 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Brazil, Poland, Australia, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT) (time frame: Week 24 or EOT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03204331, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.

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