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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03654274




Registration number
NCT03654274
Ethics application status
Date submitted
29/08/2018
Date registered
31/08/2018

Titles & IDs
Public title
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Scientific title
SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain
Secondary ID [1] 0 0
2017-004066-10
Secondary ID [2] 0 0
MVT-601-3103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Relugolix
Treatment: Drugs - Estradiol/norethindrone acetate

Experimental: Relugolix plus E2/NETA - Relugolix co-administered with E2/NETA for 80 weeks.


Treatment: Drugs: Relugolix
Relugolix 40-mg tablet administered orally once daily

Treatment: Drugs: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104
Timepoint [3] 0 0
Week 104
Primary outcome [4] 0 0
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104
Timepoint [4] 0 0
Week 104
Secondary outcome [1] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104
Timepoint [2] 0 0
Week 104
Secondary outcome [3] 0 0
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 52
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 104
Timepoint [4] 0 0
Week 104
Secondary outcome [5] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104
Timepoint [6] 0 0
Week 104
Secondary outcome [7] 0 0
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104
Timepoint [9] 0 0
Week 104
Secondary outcome [10] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104
Timepoint [11] 0 0
Week 104
Secondary outcome [12] 0 0
Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104
Timepoint [12] 0 0
Week 104
Secondary outcome [13] 0 0
Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104
Timepoint [13] 0 0
Week 104
Secondary outcome [14] 0 0
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 52
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104
Timepoint [16] 0 0
Week 104
Secondary outcome [17] 0 0
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 52
Timepoint [17] 0 0
Week 52
Secondary outcome [18] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52
Timepoint [18] 0 0
Week 52
Secondary outcome [19] 0 0
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104
Timepoint [19] 0 0
Week 104
Secondary outcome [20] 0 0
Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52
Timepoint [20] 0 0
Week 52
Secondary outcome [21] 0 0
Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 104
Timepoint [21] 0 0
Week 104
Secondary outcome [22] 0 0
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52
Timepoint [22] 0 0
Week 52
Secondary outcome [23] 0 0
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104
Timepoint [23] 0 0
Week 104
Secondary outcome [24] 0 0
Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52
Timepoint [24] 0 0
Week 52
Secondary outcome [25] 0 0
Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104
Timepoint [25] 0 0
Week 104
Secondary outcome [26] 0 0
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52
Timepoint [26] 0 0
Week 52
Secondary outcome [27] 0 0
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104
Timepoint [27] 0 0
Week 104
Secondary outcome [28] 0 0
Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52
Timepoint [28] 0 0
Week 52
Secondary outcome [29] 0 0
Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104
Timepoint [29] 0 0
Week 104
Secondary outcome [30] 0 0
Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52
Timepoint [30] 0 0
Week 52
Secondary outcome [31] 0 0
Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104
Timepoint [31] 0 0
Week 104
Secondary outcome [32] 0 0
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52
Timepoint [32] 0 0
Week 52
Secondary outcome [33] 0 0
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104
Timepoint [33] 0 0
Week 104
Secondary outcome [34] 0 0
Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52
Timepoint [34] 0 0
Week 52
Secondary outcome [35] 0 0
Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104
Timepoint [35] 0 0
Week 104
Secondary outcome [36] 0 0
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52
Timepoint [36] 0 0
Week 52
Secondary outcome [37] 0 0
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104
Timepoint [37] 0 0
Week 104

Eligibility
Key inclusion criteria
Key

1. Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102.
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.

Key
Minimum age
18 Years
Maximum age
51 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
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
22/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2023
Sample size
Target
Accrual to date
Final
802
Recruitment in Australia
Recruitment state(s)
NSW,NSQLD,SA,WA
Recruitment hospital [1] 0 0
Sydney - Sydney
Recruitment hospital [2] 0 0
Wollongong - Wollongong
Recruitment hospital [3] 0 0
Taringa - Taringa
Recruitment hospital [4] 0 0
Adelaide - Adelaide
Recruitment hospital [5] 0 0
Nedlands - Nedlands
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2522 - Wollongong
Recruitment postcode(s) [3] 0 0
4068 - Taringa
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
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South Carolina
Country [21] 0 0
United States of America
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Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Argentina
State/province [26] 0 0
Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Santa Fe
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordoba
Country [29] 0 0
Belgium
State/province [29] 0 0
Flemish Brabant
Country [30] 0 0
Belgium
State/province [30] 0 0
Hainaut
Country [31] 0 0
Belgium
State/province [31] 0 0
Oost-vlaanderen
Country [32] 0 0
Belgium
State/province [32] 0 0
Brussels
Country [33] 0 0
Brazil
State/province [33] 0 0
Rio Grande Do Sul
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Brazil
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Sao Paulo
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Sofiya
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Blagoevgrad
Country [37] 0 0
Bulgaria
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Pleven
Country [38] 0 0
Bulgaria
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Stara Zagora
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Bulgaria
State/province [39] 0 0
Varna
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Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
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Canada
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Quebec
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Chile
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Santiago
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Czechia
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Jihocesky Kraj
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Czechia
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Jihocesky
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Czechia
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Jihormoravsky Kraj
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Czechia
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Kralovehradecky
Country [48] 0 0
Czechia
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Praha
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Czechia
State/province [49] 0 0
Olomouc
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Czechia
State/province [50] 0 0
Praha 8 - Liben
Country [51] 0 0
Czechia
State/province [51] 0 0
Ceské Budejovice
Country [52] 0 0
Finland
State/province [52] 0 0
Eastern Finland
Country [53] 0 0
Finland
State/province [53] 0 0
Southern Finland
Country [54] 0 0
Finland
State/province [54] 0 0
Oulu
Country [55] 0 0
Georgia
State/province [55] 0 0
Tbilisi
Country [56] 0 0
Hungary
State/province [56] 0 0
Bacs-kiskun
Country [57] 0 0
Hungary
State/province [57] 0 0
Baranya
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Hungary
State/province [58] 0 0
Bekes
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Hungary
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Csongrad
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Hungary
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Hajdu-bihar
Country [61] 0 0
Hungary
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Szabolcs-szatmar-bereg
Country [62] 0 0
Italy
State/province [62] 0 0
Cagliari
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Italy
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Catanzaro
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Roma
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New Zealand
State/province [67] 0 0
Auckland
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New Zealand
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Manawatu-wanganui
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New Zealand
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Christchurch
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Poland
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Lodzkie
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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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Podlaskie
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Poland
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Slaskie
Country [75] 0 0
Poland
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Wielkopolskie
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Poland
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Zachodniopomorskie
Country [77] 0 0
Portugal
State/province [77] 0 0
Lisboa
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Portugal
State/province [78] 0 0
Coimbra
Country [79] 0 0
Portugal
State/province [79] 0 0
Covilhã
Country [80] 0 0
Portugal
State/province [80] 0 0
Porto
Country [81] 0 0
Romania
State/province [81] 0 0
Brasov
Country [82] 0 0
Romania
State/province [82] 0 0
Bucuresti
Country [83] 0 0
Romania
State/province [83] 0 0
Bucure?ti
Country [84] 0 0
South Africa
State/province [84] 0 0
Eastern Cape
Country [85] 0 0
South Africa
State/province [85] 0 0
Gauteng
Country [86] 0 0
South Africa
State/province [86] 0 0
Kwazulu-natal
Country [87] 0 0
South Africa
State/province [87] 0 0
Western Cape
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Valencia
Country [90] 0 0
Ukraine
State/province [90] 0 0
Kiev City
Country [91] 0 0
Ukraine
State/province [91] 0 0
Kiev
Country [92] 0 0
Ukraine
State/province [92] 0 0
Chernivtsi
Country [93] 0 0
Ukraine
State/province [93] 0 0
Ivano-Frankivsk
Country [94] 0 0
Ukraine
State/province [94] 0 0
Kharkiv
Country [95] 0 0
Ukraine
State/province [95] 0 0
Kyiv
Country [96] 0 0
Ukraine
State/province [96] 0 0
Zaporizhzhya

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 are available at https://clinicaltrials.gov/study/NCT03654274