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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis Related Pain
• Intervention / Treatment: Drug: Relugolix; Drug: Estradiol/norethindrone acetate; Drug: Estradiol/norethindrone acetate placebo; Drug: Relugolix placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 623
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Sydney
    • Wollongong, New South Wales, Australia, 2522
      • Wollongong
  • Queensland
    • Sherwood, Queensland, Australia, 4075
      • Sherwood
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Adelaide
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Nedlands
• Brazil
  • RIO Grande DO SUL
    • Passo Fundo, RIO Grande DO SUL, Brazil, 99010-080
      • Passo Fundo
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90510-040
      • Porto Alegre
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
      • Porto Alegre
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
      • Porto Alegre
  • SAO Paulo
    • Porto Alegre, SAO Paulo, Brazil, 90035-903
      • Porto Alegre
    • São Bernardo do Campo, SAO Paulo, Brazil, 09715-090
      • São Bernardo do Campo
    • São Paulo, SAO Paulo, Brazil, 01317-000
      • Sao Paulo
    • São Paulo, SAO Paulo, Brazil, 01323-900
      • Sao Paulo
    • São Paulo, SAO Paulo, Brazil, 04023-062
      • Sao Paulo
    • São Paulo, SAO Paulo, Brazil, 04266-010
      • Sao Paulo
    • São Paulo, SAO Paulo, Brazil, 04708-001
      • Sao Paulo
• Chile
  • Santiago, Chile, 7510186
    • Santiago
  • Santiago, Chile, 8320165
    • Santiago
  • Santiago, Chile, 8360160
    • Santiago
  • Santiago, Chile, 8880465
    • Santiago
• Czechia
  • České Budějovice, Czechia, 370 01
    • České Budějovice
  • Jihocesky KRAJ
    • Písek, Jihocesky KRAJ, Czechia, 39701
      • Písek
  • Jihormoravsky KRAJ
    • Tábor, Jihormoravsky KRAJ, Czechia, 390 03
      • Tábor
  • Praha
    • Praha 2, Praha, Czechia, 128 08
      • Praha 2
• Georgia
  • Borjomi
    • Tbilisi, Borjomi, Georgia, 0159
      • Tbilisi
• Italy
  • Catanzaro, Italy, 88100
    • Catanzaro
  • Napoli, Italy, 80131
    • Napoli
  • Pavia, Italy, 27100
    • Pavia
  • Roma, Italy, 00168
    • Roma
  • Cagliari
    • Monserrato, Cagliari, Italy, 09042
      • Monserrato
• New Zealand
  • Christchurch, New Zealand, 8013
    • Christchurch
  • Auckland
    • Birkenhead, Auckland, New Zealand, 0626
      • Birkenhead
    • Remuera, Auckland, New Zealand, 1050
      • Remuera
  • Bay Of Plenty
    • Tauranga, Bay Of Plenty, New Zealand, 3112
      • Tauranga
  • Manawatu-wanganui
    • Palmerston North, Manawatu-wanganui, New Zealand, 4442
      • Palmerston North
• Poland
  • Lodzkie
    • Łódź, Lodzkie, Poland, 90-602
      • Lodz
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-064
      • Lublin
    • Lublin, Lubelskie, Poland, 20-093
      • Lublin
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-066
      • Warszawa
    • Warszawa, Mazowieckie, Poland, 02-929
      • Warszawa
    • Warszawa, Mazowieckie, Poland, 02-201
      • Warszawa
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-224
      • Bialystok
    • Białystok, Podlaskie, Poland, 15-464
      • Białystok
  • Slaskie
    • Katowice, Slaskie, Poland, 40-301
      • Katowice
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-185
      • Poznan
• Romania
  • Brasov, Romania, 500091
    • Brasov
  • Bucuresti, Romania, 012071
    • București
  • Bucuresti, Romania, 022441
    • București
  • Bucuresti
    • București, Bucuresti, Romania, 20475
      • București
• Sweden
  • Skane
    • Malmö, Skane, Sweden, 20502
      • Malmo
• United States
  • Alabama
    • Andalusia, Alabama, United States, 36420
      • Andalusia
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Washington DC
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura
    • DeLand, Florida, United States, 32720
      • Deland
    • Hialeah, Florida, United States, 33012
      • Hialeah
    • Hialeah, Florida, United States, 33016
      • Hialeah
    • Margate, Florida, United States, 33063
      • Margate
    • Miami, Florida, United States, 33176
      • Miami
    • Port Saint Lucie, Florida, United States, 34952
      • Port St. Lucie
    • Tampa, Florida, United States, 33606
      • Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Atlanta
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Idaho Falls
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Park Ridge
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • Lafayette
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Covington
    • Marrero, Louisiana, United States, 70072
      • Marrero
  • Maryland
    • Towson, Maryland, United States, 21204
      • Towson
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Saginaw
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Omaha
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque
  • New York
    • New York, New York, United States, 10038
      • New York
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • New Bern
  • Ohio
    • Akron, Ohio, United States, 44313
      • Akron
    • Columbus, Ohio, United States, 43231
      • Columbus
    • Columbus, Ohio, United States, 43235
      • Columbus
    • Franklin, Ohio, United States, 45005
      • Franklin
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Columbia
    • Spartanburg, South Carolina, United States, 29301
      • Spartanburg
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga
  • Texas
    • Beaumont, Texas, United States, 77702
      • Beaumont
    • Corpus Christi, Texas, United States, 78412
      • Corpus Christi
    • Dallas, Texas, United States, 75231
      • Dallas
    • Fort Worth, Texas, United States, 76104
      • Fort Worth
    • Houston, Texas, United States, 77054
      • Houston
    • Irving, Texas, United States, 75062
      • Irving
    • San Antonio, Texas, United States, 78258
      • San Antonio
    • Sugar Land, Texas, United States, 77479
      • Sugar Land
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • Pleasant Grove
    • Salt Lake City, Utah, United States, 84102
      • Salt Lake City
  • Virginia
    • Virginia Beach, Virginia, United States, 23502
      • Virginia Beach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Key Inclusion Criteria:

1. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form.
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.

Key Exclusion Criteria:

1. Has a history of chronic pelvic pain that is not caused by endometriosis.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relugolix plus E2/NETA (Group A); Relugolix co-administered with E2/NETA for 24 weeks.	Drug: Relugolix; Relugolix 40-mg tablet administered orally once daily.; Other Names: TAK-385; MVT-601; Drug: Estradiol/norethindrone acetate; Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.; Other Names: E2/NETA
Experimental: 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.	Drug: Relugolix; Relugolix 40-mg tablet administered orally once daily.; Other Names: TAK-385; MVT-601; Drug: Estradiol/norethindrone acetate; Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.; Other Names: E2/NETA; Drug: 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 Comparator: Placebo (Group C); Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.	Drug: 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.; Drug: Relugolix placebo; Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 24 or EOT
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.	Week 24 or EOT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 24
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.	Baseline, Week 24 or EOT
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.	Baseline, Week 24 or EOT
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.	Baseline, Week 24 or EOT
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.	Week 24 or EOT
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.	Baseline, Week 24 or EOT
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.	Baseline, Week 24 or EOT
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.	Baseline to Week 24
Dysmenorrhea Responder Rate By Month	The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.	Baseline to Week 24
NMPP Responder Rate By Month	The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.	Baseline to Week 24
Change In Dysmenorrhea NRS Score By Month	Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.	Baseline to Week 24
Change In NMPP NRS Score By Month	Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.	Baseline to Week 24
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.	Baseline to Week 24
Change In Dyspareunia NRS Score By Month	Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.	Baseline to Week 24
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.	Baseline, Week 24 or EOT
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.	Baseline, Week 24 or EOT
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.	Baseline, Week 24 or EOT
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.	Baseline, Week 24
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.	Week 24
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.	Baseline, Week 24
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.	Week 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.	Baseline, Week 24
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.	Week 24
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.	Baseline, Week 24
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.	Week 24
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.	Week 24
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.	Week 24
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.	Week 24
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.	Baseline, Week 24
Change From Baseline In The EHP-30 Scale Total Score At Week 24	Assessed using the total score of the EHP-30 questionnaire.	Baseline, Week 24
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.	Baseline, Week 24
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.	Baseline, Week 24
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.	Baseline, Week 24
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.	Week 24 or EOT
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.	Week 24 or EOT
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.	Baseline, Week 24
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.	Baseline to Week 24
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.	Baseline, Week 12
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.	Baseline, Week 24
Percentage Of Participants Experiencing Vasomotor Symptoms At Week 12 Between Group A And B		Week 12
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.	Baseline, Week 24
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.	Baseline, Week 24
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.	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Myovant Sciences GmbH

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2022 Aug 27;400(10353):660.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Dysmenorrhea; Endometriosis
• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Androgen Antagonists; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate; Norethindrone; Norethindrone Acetate; Relugolix
• Other Study ID Numbers: MVT-601-3102; 2017-001632-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No