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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03085095




Registration number
NCT03085095
Ethics application status
Date submitted
9/03/2017
Date registered
21/03/2017

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
Scientific title
HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
Secondary ID [1] 0 0
2017-000160-15
Secondary ID [2] 0 0
MVT-601-3201
Universal Trial Number (UTN)
Trial acronym
HERO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Relugolix
Treatment: Drugs - Leuprolide Acetate

Experimental: Relugolix - Relugolix for 48 weeks

Active comparator: Leuprolide Acetate - Leuprolide acetate for 48 weeks


Treatment: Drugs: Relugolix
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1

Treatment: Drugs: Leuprolide Acetate
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sustained Castration Rate
Timepoint [1] 0 0
From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)
Secondary outcome [1] 0 0
Castration Rate At Week 1 Day 4
Timepoint [1] 0 0
Week 1 Day 4 (Day 4)
Secondary outcome [2] 0 0
Castration Rate At Week 3 Day 1
Timepoint [2] 0 0
Week 3 Day 1 (Day 15)
Secondary outcome [3] 0 0
Confirmed Prostate-specific Antigen (PSA) Response Rate
Timepoint [3] 0 0
Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29)
Secondary outcome [4] 0 0
Profound Castration Rate At Week 3 Day 1 (Day 15)
Timepoint [4] 0 0
Week 3 Day 1 (Day 15)
Secondary outcome [5] 0 0
Follicle-stimulating Hormone (FSH) Level
Timepoint [5] 0 0
Week 25 Day 1 (Day 169)
Secondary outcome [6] 0 0
PSA Response Rate At Week 3 Day 1
Timepoint [6] 0 0
Week 3 Day 1 (Day 15)
Secondary outcome [7] 0 0
PSA Response Rate At Week 5 Day 1
Timepoint [7] 0 0
Week 5 Day 1 (Day 29)
Secondary outcome [8] 0 0
Testosterone Recovery Rate
Timepoint [8] 0 0
Day 90 follow-up
Secondary outcome [9] 0 0
Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1
Timepoint [9] 0 0
Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337)
Secondary outcome [10] 0 0
Profound Castration Rate At Week 1 Day 4 (Day 4)
Timepoint [10] 0 0
At Week 1 Day 4 (Day 4)
Secondary outcome [11] 0 0
Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1
Timepoint [11] 0 0
Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337)
Secondary outcome [12] 0 0
Undetectable PSA Rate
Timepoint [12] 0 0
Week 25 Day 1 (Day 169)
Secondary outcome [13] 0 0
Rate Of PSA Progression-free Survival
Timepoint [13] 0 0
Week 49 Day 1 (Day 337)
Secondary outcome [14] 0 0
Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30
Timepoint [14] 0 0
Baseline, Week 49 Day 1 (Day 337)
Secondary outcome [15] 0 0
Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30
Timepoint [15] 0 0
Baseline, Week 49 Day 1 (Day 337)
Secondary outcome [16] 0 0
Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains
Timepoint [16] 0 0
Baseline, Week 49 Day 1 (Day 337)
Secondary outcome [17] 0 0
Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25
Timepoint [17] 0 0
Baseline, Week 49 Day 1 (Day 337)
Secondary outcome [18] 0 0
Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L)
Timepoint [18] 0 0
Baseline, Week 49 Day 1 (Day 337)
Secondary outcome [19] 0 0
Percent Change From Baseline In Serum Concentrations Of Luteinizing Hormone
Timepoint [19] 0 0
Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Secondary outcome [20] 0 0
Percent Change From Baseline In Serum Concentrations Of FSH
Timepoint [20] 0 0
Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Secondary outcome [21] 0 0
Percent Change From Baseline In Serum Concentrations Of Dihydrotestosterone
Timepoint [21] 0 0
Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Secondary outcome [22] 0 0
Percent Change From Baseline In Serum Concentrations Of Sex Hormone-Binding Globulin
Timepoint [22] 0 0
Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Secondary outcome [23] 0 0
Maximum Observed Plasma Concentration (Cmax) Of Relugolix
Timepoint [23] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
Secondary outcome [24] 0 0
Area Under The Concentration-Time Curve (AUC0-t) Of Relugolix
Timepoint [24] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
Secondary outcome [25] 0 0
Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix
Timepoint [25] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2

Eligibility
Key inclusion criteria
Key

1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
2. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with 1 of the following clinical disease state presentations:

1. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery; or
2. Newly diagnosed androgen-sensitive metastatic disease; or
3. Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent.
3. Has a serum testosterone at the Screening visit of = 150 ng/dL (5.2 nanomoles [nmol]/liter [L]).
4. Has a serum PSA concentration at the Screening visit of > 2.0 ng/milliliter (mL) (2.0 microgram [µg]/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 µg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 µg/L) above the post interventional nadir.
5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy.
2. Previously received gonadotropin-releasing hormone analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for = 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot.
3. Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen).
4. Metastases to brain per prior clinical evaluation.
5. Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months.
6. Active conduction system abnormalities.
7. Uncontrolled hypertension.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/11/2021
Sample size
Target
Accrual to date
Final
1134
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Camperdown - Camperdown
Recruitment hospital [2] 0 0
Tweed Heads - Tweed Heads
Recruitment hospital [3] 0 0
Wahroonga - Wahroonga
Recruitment hospital [4] 0 0
Redcliffe - Redcliffe
Recruitment hospital [5] 0 0
Southport - Southport
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
4020 - Redcliffe
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
Austria
State/province [22] 0 0
Linz
Country [23] 0 0
Belgium
State/province [23] 0 0
Oost-Vlaanderen
Country [24] 0 0
Belgium
State/province [24] 0 0
Brussels
Country [25] 0 0
Belgium
State/province [25] 0 0
Kortrijk
Country [26] 0 0
Brazil
State/province [26] 0 0
Bahia
Country [27] 0 0
Brazil
State/province [27] 0 0
Piauí
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio Grande Do Norte
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande Do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
Santa Catarina
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Curitiba
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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China
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Jiangsu
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Jilin
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China
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Shanghai
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China
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Shanxi
Country [42] 0 0
China
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Beijing
Country [43] 0 0
China
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Chongqing
Country [44] 0 0
China
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Hangzhou
Country [45] 0 0
China
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Lanzhou
Country [46] 0 0
China
State/province [46] 0 0
Nanchang
Country [47] 0 0
China
State/province [47] 0 0
Suzhou
Country [48] 0 0
Denmark
State/province [48] 0 0
Aalborg
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Denmark
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Aarhus
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Denmark
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Herlev
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Denmark
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Vejle
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Finland
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Helsinki
Country [53] 0 0
Finland
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Seinäjoki
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Finland
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Tampere
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Finland
State/province [55] 0 0
Turku
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France
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Bas-Rhin
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France
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Rhone
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France
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Val-de-Marne
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France
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Lyon
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Dresden
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Germany
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Lübeck
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Germany
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Münster
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Emilia-Romagna
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Lazio
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Italy
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Lombardia
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Piemonte
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Toscana
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Milano
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Isikawa
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Kanagawa
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Miyagi
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Osaka
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Tokyo
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Japan
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Chiba
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Fukuoka
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Hiroshima
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Kita
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Japan
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Kyoto
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Japan
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Maebashi
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Japan
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Nagasaki
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Sapporo
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Ube
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Seoul
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Netherlands
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Noord Brabant
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Noord Holland
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Netherlands
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Sneek
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Tauranga
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Poland
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Lubelskie
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Poland
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Mazowieckie
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Poland
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Pomorskie
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Poland
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Katowice
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Slovakia
State/province [102] 0 0
Bratislava
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Slovakia
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Košice
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Slovakia
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Martin
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Slovakia
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Nitra
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Slovakia
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Poprad
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Slovakia
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Prešov
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Slovakia
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Trencín
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Slovakia
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Šala
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Spain
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A Coruna
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Orebro Ian
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Sweden
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Sodermandlands Ian
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Sweden
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Uppsala Lan
Country [119] 0 0
Sweden
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Malmö
Country [120] 0 0
Taiwan
State/province [120] 0 0
Kaohsiung City
Country [121] 0 0
Taiwan
State/province [121] 0 0
Taipei
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Devon
Country [123] 0 0
United Kingdom
State/province [123] 0 0
North Lincolnshire
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Nottingham
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Rhyl

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Myovant Sciences GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Myovant Medical Monitor
Address 0 0
Myovant Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03085095