Clinical trial NCT04003389: A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
Official title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hot Flashes
Keywords: menopause
fezolinetant
ESN364
vasomotor symptoms
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 1831
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life.

The purpose of this study was to find out how safe it is for these women to take fezolinetant in long term (up to 52 weeks). To do that, the study looked at the number and severity of the "adverse events." Those were the side effects that study participants had while they were in the study.

The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo was a dummy treatment that looked like medicine but did not have any medicine in it.) Women in this study were picked for 1 of the 3 study treatments by chance alone. The study participants took study treatment for 52 weeks.

This study was "double-blinded." That means that the study participants and the study doctors did not know who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg or placebo).

At weeks 2 and 4 and then once a month, the study participants went to the hospital or clinic for a check-up. They were asked about medications, side effects and how they felt. Other checks included physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine were collected for laboratory tests. At some study visits, study participants completed questionnaires that were about their quality of life. At the first and last study visits, they had a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA created pictures of the inside of these areas with low-dose x-rays. (The dose was approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still had their uterus had 2 more tests done at the first and last study visits. One of the 2 tests was endometrial biopsy. This test involved removing a small amount of tissue from the inside lining of the uterus. The tissue was then checked under a microscope. The other test was transvaginal ultrasound. It used sound waves to create pictures of the organs in the pelvis. The sound waves were transmitted by a probe (transducer), which was placed inside the vagina. Study participants might have had a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not had this test done in the last 12 months had it done at the first study visit. They had done at the last study visit if they were due for their screening mammogram and their own doctor agreed.

The last check-up at the hospital or clinic was at 3 weeks after the last dose of study treatment.

Detailed description: This study consisted of a screening period and a 52 week treatment period. Safety follow up occurred 3 weeks after the last dose of study drug.

Eligibility criteria: Inclusion Criteria:

* Subject has a body mass index ≥ 18 kg/m\^2 and ≤ 38 kg/m\^2.
* Subject must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per 1 of the following criteria at the screening visit:

  * Spontaneous amenorrhea for ≥ 12 consecutive months
  * Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (follicle stimulating hormone \> 40 IU/L), or
  * Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit.
* Subject is seeking treatment for relief for VMS associated with menopause.
* Subject is in good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, performed at the screening visit; hematology and biochemistry parameters; pulse rate and/or blood pressure; and ECG within the reference range for the population studied, or showing no clinically relevant deviations.
* Subject has documentation of a normal/negative or no clinically significant mammogram findings (obtained at screening or within the prior 12 months of study enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.
* Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and at week 52 end of treatment (EOT). For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the early discontinuation (ED) visit.
* Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT) or the ED visit for subjects who are withdrawn from the study prior to completion, and any time during the study in the case of uterine bleeding. The endometrial biopsy obtained at screening must be considered evaluable.
* Subject has documentation of a normal or not clinically significant Papanicolaou (Pap) test (or equivalent cervical cytology) within the previous 12 months or at screening.
* Subject has a negative urine pregnancy test at screening.
* Subject has a negative serology panel (i.e., negative hepatitis B surface antigen, negative hepatitis C virus antibody and negative human immunodeficiency virus antibody screens) at screening.
* Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

* Subject uses a prohibited therapy (strong or moderate cytochrome P450 \[CYP\] 1A2 inhibitors, hormone replacement therapy \[HRT\], hormonal contraceptive, any treatment for VMS \[prescription, over the counter or herbal\]) or is not willing to wash out and discontinue such drugs for the full extent of the study.
* Subject has a known substance abuse or alcohol addiction within 6 months of screening.
* Subject has previous or current history of a malignant tumor, except for basal cell carcinoma.
* Subject's systolic blood pressure is ≥ 130 mmHg or diastolic blood pressure is ≥ 80 mmHg based on the average of 2 to 3 readings, on at least 2 different occasions within the screening period.

  * Subjects who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
  * Subjects with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
* Subject has a history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.
* Subject has an unacceptable result from the TVU assessment at screening, i.e., full length of endometrial cavity cannot be visualized or presence of a clinically significant finding.
* Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer, or other clinically significant findings at screening.
* Subject has a history within the last 6 months of undiagnosed uterine bleeding.
* Subject has a history of seizures or other convulsive disorders.
* Subject has a medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine or gynecological disease) or malignancy that could confound interpretation of the study outcome.
* Subject has active liver disease, jaundice or elevated liver aminotransferases (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]), elevated total or direct bilirubin, elevated international normalized ratio (INR), or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 times the upper limit of normal (ULN) can be enrolled if total and direct bilirubin are normal. Patients with mildly elevated ALP (up to 1.5 x ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Patients with Gilbert's syndrome with elevated total bilirubin may be enrolled as long as direct bilirubin, hemoglobin and reticulocytes are normal.
* Subject has creatinine \> 1.5 x ULN; or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula ≤ 59 mL/min per 1.73 m\^2 at the screening visit.
* Subject has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or who is at significant risk to commit suicide, as assessed at screening and at the time of visit 2 (randomization).
* Subject has previously been enrolled in a clinical trial with fezolinetant.
* Subject is participating concurrently in another interventional study or participated in an interventional study within 28 days prior to screening, or received any investigational drug within 28 days or within 5 half-lives prior to screening, whichever is longer.
* Subject is unable or unwilling to complete the study procedures.
* Subject has any condition which makes the subject unsuitable for study participation.
* Subject has had a partial or full hysterectomy.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)
measure: Number of Participants With Mild, Moderate and Severe TEAE
timeFrame: From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)
measure: Percentage of Participants With Endometrial Hyperplasia
timeFrame: Baseline Up to 52 weeks
measure: Percentage of Participants With Endometrial Cancer
timeFrame: Baseline Up to 52 weeks
Secondary outcomes:
measure: Change From Baseline in Endometrial Thickness at Week 52
timeFrame: Baseline and week 52
measure: Percentage of Participants With Disordered Proliferative Endometrium
timeFrame: Baseline Up to 52 weeks
measure: Change From Baseline in Bone Mineral Density (BMD) at Hip at Week 52
timeFrame: Baseline and week 52
measure: Change From Baseline in Trabecular Bone Score (TBS) at Hip at Week 52
timeFrame: Baseline and week 52
measure: Change From Baseline in BMD at Spine at Week 52
timeFrame: Baseline and week 52
measure: Change From Baseline in TBS at Spine at Week 52
timeFrame: Baseline and week 52
measure: Number of Participants With Suicidal Ideation and/or Behaviour as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, week 12, week 24, week 52 and follow-up (week 55)
measure: Number of Participants With Self-injurious Behavior Without Suicidal Intent as Assessed by C-SSRS
timeFrame: Baseline, week 12, week 24, week 52 and follow-up (week 55)
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: SEC Clinical Research
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Birmingham
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facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Ensley
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Mesa
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facility: Mesa Obstetricians and Gynecologists
state: Arizona
city: Phoenix
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facility: Medpharmics LLC
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city: Phoenix
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facility: Precision Trials
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city: Tucson
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facility: Del Sol Research Management
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city: Tucson
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facility: Visions Clinical Research - Tuscon
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Canoga Park
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facility: Hope Research Institute
state: California
city: Canoga Park
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facility: Alliance Research Inc
state: California
city: Huntington Beach
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facility: Marvel Clinical Research
state: California
city: La Mesa
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facility: Grossmont Center for Clinical Research
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center, Inc.
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Panorama
state: California
city: Oceanside
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facility: Excell Research
state: California
city: Sacramento
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facility: Clinical Trials Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
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city: San Diego
country: United States
facility: Wake Research Associates, LLC
state: California
city: San Diego
country: United States
facility: Women's Healthcare Affiliates
state: California
city: Santa Ana
country: United States
facility: CITrials, Inc
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials
state: California
city: Upland
country: United States
facility: Women's Medical Group of Upland
state: California
city: Valley Village
country: United States
facility: Bayview Research Group
state: California
city: Denver
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facility: Downtown Women's Health Care
state: Colorado
city: Denver
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facility: Horizons Clincial Research Center LLC
state: Colorado
city: New London
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facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Washington
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facility: Emerson Clinical Research institute
state: District of Columbia
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Coral Springs
country: United States
facility: Precision Clinical Research
state: Florida
city: Crystal River
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facility: Nature Coast Clinical Research
state: Florida
city: DeLand
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facility: Avail Clinical Research, LLC
state: Florida
city: Doral
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facility: Universal Axon Clinical Research
state: Florida
city: Fleming Island
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facility: Fleming Island Center for Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Gainesville
country: United States
facility: Florida Medical Research
state: Florida
city: Hialeah
country: United States
facility: Vital Pharma Research Inc.
state: Florida
city: Jupiter
country: United States
facility: Health Awareness
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Medical Research Center of Miami II
state: Florida
city: Miami
country: United States
facility: Medical Research Centers of South Florida, Inc.
state: Florida
city: Miami
country: United States
facility: Florida International Research Center
state: Florida
city: Miami
country: United States
facility: Spotlight research center
state: Florida
city: Miami
country: United States
facility: Med Research Of Florida, LLC
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data Inc
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare LLC
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Orlando
country: United States
facility: Cornerstone Research Institute
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Palm Harbor
country: United States
facility: Sunset Point Medical Associates
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research
state: Florida
city: Ponte Vedra
country: United States
facility: St. Johns Center for Clinical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC
state: Florida
city: The Villages
country: United States
facility: Premier Medical Associates
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta LLC
state: Georgia
city: Duluth
country: United States
facility: NuDirections Clinical Research
state: Georgia
city: Riverdale
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research
state: Georgia
city: Snellville
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Idaho Falls
country: United States
facility: The Healing Sanctuary, LLC
state: Idaho
city: Champaign
country: United States
facility: Womens Health USA, Inc.
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Clinical Research Institute
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group, Llc
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research
state: Indiana
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: Crowley
country: United States
facility: Avant Research Associates, LLC
state: Louisiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates
state: Louisiana
city: Metairie
country: United States
facility: Medpharmics, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research Inc
state: Maryland
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, Llc
state: Michigan
city: Missoula
country: United States
facility: Montana Medical Research Inc
state: Montana
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada (CRCN)
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: Las Vegas
country: United States
facility: Office Of Edmond Pack, Md
state: Nevada
city: Las Vegas
country: United States
facility: Dr.R. Garn Mabey, MD,Office Of
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute, LLC
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence OBGYN Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: West Seneca
country: United States
facility: Circuit Clinical
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates LLC
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Durham
country: United States
facility: Carolina women's research and wellness center
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Insitute for Clinical Research
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Cincinnati
country: United States
facility: CTI
state: Ohio
city: Cincinnati
country: United States
facility: Greater Cincinnati OB/GYN
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare For Women
state: Ohio
city: Englewood
country: United States
facility: Hwc Women's Research Center
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Erie
country: United States
facility: OB-GYN Associates
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga GYN-Oncology
state: Tennessee
city: Chattanooga
country: United States
facility: WR Clinsearch, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Tennessee
city: Memphis
country: United States
facility: Medical Research Center of Memphis, LLC
state: Tennessee
city: Murfreesboro
country: United States
facility: International Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Tekton Research - Georgetown
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research, LLC
state: Texas
city: Bryan
country: United States
facility: DiscoveResarch, Inc.
state: Texas
city: Houston
country: United States
facility: Advances in Health
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research, LLC
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: Plano
country: United States
facility: ClinRx Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research Centers, Inc.
state: Texas
city: Sugar Land
country: United States
facility: Excel Clinical Research, LLC
state: Texas
city: Murray
country: United States
facility: EPIC Medical Research
state: Utah
city: Salt Lake City
country: United States
facility: Advanced Clinical Research-Old Farm OB/GYN (Utah)
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads Inc
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
city: Brampton
country: Canada
facility: Site CA15005
state: Ontario
city: Burlington
country: Canada
facility: Site CA15006
state: Ontario
city: Sarnia
country: Canada
facility: Site CA15010
state: Ontario
city: Toronto
country: Canada
facility: Site CA15007
state: Ontario
city: Levis
country: Canada
facility: Site CA15012
state: Quebec
city: Point Claire
country: Canada
facility: Site CA15004
state: Quebec
city: Sherbrooke
country: Canada
facility: Site CA15003
state: Quebec
city: Victoriaville
country: Canada
facility: Site CA15001
state: Quebec
city: Quebec
country: Canada
facility: Site CA15002
city: Quebec
country: Canada
facility: Site CA15009
city: Vodnany
country: Czechia
facility: Site CZ42008
state: Jihocesky
city: Olomouc
country: Czechia
facility: Site CZ42001
city: Olomouc
country: Czechia
facility: Site CZ42003
city: Pisek
country: Czechia
facility: Site CZ42010
city: Praha 2
country: Czechia
facility: Site CZ42009
city: Tabor 3
country: Czechia
facility: Site CZ42005
city: Riga
country: Latvia
facility: Site LV37102
city: Riga
country: Latvia
facility: Site LV37101
city: Bialystok
country: Poland
facility: Site PL48004
city: Bydgoszcz
country: Poland
facility: Site PL48005
city: Katowice
country: Poland
facility: Site PL48002
city: Katowice
country: Poland
facility: Site PL48019
city: Lublin
country: Poland
facility: Site PL48006
city: Lublin
country: Poland
facility: Site PL48014
city: Poznan
country: Poland
facility: Site PL48016
city: Szczecin
country: Poland
facility: Site PL48010
city: Warsaw
country: Poland
facility: Site PL48020
city: Warszawa
country: Poland
facility: Site PL48003
city: Warszawa
country: Poland
facility: Site PL48007
city: Centelles
country: Spain
facility: Site ES34005
city: Madrid
country: Spain
facility: Site ES34002
city: Zaporizhzhya
country: Ukraine
facility: Site UA38004
state: Zaporizka Oblast
city: Kiev
country: Ukraine
facility: Site UA38006
city: Wokingham
country: United Kingdom
facility: Site GB44003
state: Berkshire
city: Sidcup
country: United Kingdom
facility: Site GB44008
state: Kent
city: Corby
country: United Kingdom
facility: Site GB44005
state: Northamptonshire
city: Kenilworth
country: United Kingdom
facility: Site GB44004
state: Warwickshire
city: Middlesex
country: United Kingdom
facility: Site GB44006
city: Romford
country: United Kingdom
facility: Site GB44007
city: Shipley
country: United Kingdom
facility: Site GB44001
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Executive Medical Director
role: STUDY_DIRECTOR
References: