Skylight 4: A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
Study Details
Study Description
Brief Summary
This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life.
The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study.
The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) Women in this study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks.
This study is "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo).
At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. At the first and last study visits, they will have a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA creates pictures of the inside of these areas with low-dose x-rays. (The dose is approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have 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 have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees.
The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study will consist of a screening period and a 52 week treatment period. Safety follow up will occur 3 weeks after the last dose of study drug.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: low dose fezolinetant Participants will receive low dose fezolinetant for 52 weeks. |
Drug: fezolinetant
administered orally
|
| Experimental: high dose fezolinetant Participants will receive high dose fezolinetant for 52 weeks. |
Drug: fezolinetant
administered orally
|
| Placebo Comparator: placebo Participants will receive placebo for 52 weeks. |
Drug: placebo
administered orally
|
Outcome Measures
Primary Outcome Measures
- Frequency of Adverse Events (AE) [Up to 55 weeks]
An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.
- Severity of Adverse Events [Up to 55 weeks]
An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.
- Percentage of participants with endometrial hyperplasia [Up to 52 weeks]
Endometrial hyperplasia is thickening of the lining of the uterus. Percentage of participants will be reported.
- Percentage of participants with endometrial cancer [Up to 52 weeks]
Endometrial cancer is cancer of the lining of the uterus. Percentage of participants will be reported.
Secondary Outcome Measures
- Change from baseline in endometrial thickness [Baseline and 52 weeks]
Endometrial thickness is a measure of how thick the lining of the uterus is. Change from baseline will be reported.
- Change from baseline in bone mass density (BMD) at hip [Baseline and 52 weeks]
Bone density is the amount of bone mineral in bone tissue. The change from baseline will be reported.
- Change from baseline in trabecular bone score (TBS) at hip [Baseline and 52 weeks]
The trabecular bone score is a measure of bone texture correlated with bone microarchitecture. High TBS value means that microarchitecture bone is dense, well connected with little spaces between trabeculaes. Low TBS value means that the microarchitecture of bone is incomplete and poorly connected with wide spaces between trabeculae. Change from baseline will be reported.
- Change from baseline in bone mass density (BMD) at spine [Baseline and 52 weeks]
Bone density is the amount of bone mineral in bone tissue. Change from baseline will be reported.
- Change from baseline in trabecular bone score (TBS) at spine [Baseline and 52 weeks]
The trabecular bone score is a measure of bone texture correlated with bone microarchitecture. High TBS value means that microarchitecture bone is dense, well connected with little spaces between trabeculaes. Low TBS value means that the microarchitecture of bone is incomplete and poorly connected with wide spaces between trabeculae. Change from baseline will be reported.
- Number of participants with vital sign abnormalities and /or adverse events (AEs) [Up to 55 weeks]
Number of participants with potentially clinically significant vital sign values.
- Number of participants with laboratory value abnormalities and/or adverse events (AEs) [Up to 55 weeks]
Number of participants with potentially clinically significant laboratory values.
- Number of participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs) [Up to 52 weeks]
Number of participants with potentially clinically significant ECG values.
- Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [Up to 55 weeks]
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported.
- Percentage of participants with disordered proliferative endometrium [Up to 52 weeks]
Disordered proliferative endometrium is the unusual growth of endometrial cells or the abnormal thickening of the endometrial lining. Percentage of participants will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has a body mass index ≥ 18 kg/m2 and ≤ 38 kg/m2.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SEC Clinical Research | Andalusia | Alabama | United States | 36420 |
| 2 | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | United States | 35205 |
| 3 | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | United States | 35235 |
| 4 | Achieve Clinical Research, LLC | Ensley | Alabama | United States | 35218 |
| 5 | Mesa Obstetricians and Gynecologists | Mesa | Arizona | United States | 85209 |
| 6 | Medpharmics LLC | Phoenix | Arizona | United States | 85015 |
| 7 | Precision Trials | Phoenix | Arizona | United States | 85032 |
| 8 | Del Sol Research Management | Tucson | Arizona | United States | 85712 |
| 9 | Visions Clinical Research - Tuscon | Tucson | Arizona | United States | 85712 |
| 10 | Eclipse Clinical Research | Tucson | Arizona | United States | 85745 |
| 11 | Hope Research Institute | Canoga Park | California | United States | 91303 |
| 12 | Alliance Research Inc | Canoga Park | California | United States | 91304 |
| 13 | Marvel Clinical Research | Huntington Beach | California | United States | 92647 |
| 14 | Grossmont Center for Clinical Research | La Mesa | California | United States | 91942 |
| 15 | Downtown L.A. Research Center, Inc. | Los Angeles | California | United States | 90017 |
| 16 | National Research Institute - Panorama | Los Angeles | California | United States | 90057 |
| 17 | Excell Research | Oceanside | California | United States | 92056 |
| 18 | Clinical Trials Research | Sacramento | California | United States | 95821 |
| 19 | Northern California Research | Sacramento | California | United States | 95821 |
| 20 | Wake Research Associates, LLC | San Diego | California | United States | 92108 |
| 21 | Women's Healthcare Affiliates | San Diego | California | United States | 92111 |
| 22 | CITrials, Inc | Santa Ana | California | United States | 92705 |
| 23 | Millennium Clinical Trials | Thousand Oaks | California | United States | 91360 |
| 24 | Women's Medical Group of Upland | Upland | California | United States | 91786 |
| 25 | Bayview Research Group | Valley Village | California | United States | 91607 |
| 26 | Downtown Women's Health Care | Denver | Colorado | United States | 80209 |
| 27 | Horizons Clincial Research Center LLC | Denver | Colorado | United States | 80220 |
| 28 | Coastal Connecticut Research, LLC | New London | Connecticut | United States | 06320 |
| 29 | Emerson Clinical Research institute | Washington | District of Columbia | United States | 20011 |
| 30 | Olympian Clinical Research | Clearwater | Florida | United States | 33757 |
| 31 | Precision Clinical Research | Coral Springs | Florida | United States | 33065 |
| 32 | Nature Coast Clinical Research | Crystal River | Florida | United States | 34429 |
| 33 | Avail Clinical Research, LLC | DeLand | Florida | United States | 32720 |
| 34 | Universal Axon Clinical Research | Doral | Florida | United States | 33166 |
| 35 | Fleming Island Center for Clinical Research | Fleming Island | Florida | United States | 32003 |
| 36 | Clinical Physiology Associates | Fort Myers | Florida | United States | 33912 |
| 37 | Florida Medical Research | Gainesville | Florida | United States | 32607 |
| 38 | Vital Pharma Research Inc. | Hialeah | Florida | United States | 33016 |
| 39 | Health Awareness | Jupiter | Florida | United States | 33458 |
| 40 | Multi-Specialty Research Associates, Inc. | Lake City | Florida | United States | 32055 |
| 41 | Altus Research | Lake Worth | Florida | United States | 33461 |
| 42 | LCC Medical Research Institute, LLC | Miami | Florida | United States | 33126 |
| 43 | Medical Research Center of Miami II | Miami | Florida | United States | 33134 |
| 44 | Medical Research Centers of South Florida, Inc. | Miami | Florida | United States | 33144 |
| 45 | Florida International Research Center | Miami | Florida | United States | 33174 |
| 46 | Spotlight research center | Miami | Florida | United States | 33176 |
| 47 | Med Research Of Florida, LLC | Miami | Florida | United States | 33186 |
| 48 | New Age Medical Research Corporation | Miami | Florida | United States | 33186 |
| 49 | Suncoast Clinical Research, Inc. | New Port Richey | Florida | United States | 34652 |
| 50 | Healthcare Clinical Data Inc | North Miami | Florida | United States | 33161 |
| 51 | Sensible Healthcare LLC | Ocoee | Florida | United States | 34761 |
| 52 | Bioclinica Research | Orlando | Florida | United States | 32806 |
| 53 | Clinical Neuroscience Solutions, Inc | Orlando | Florida | United States | 32806 |
| 54 | Omega Research Consultants | Orlando | Florida | United States | 32808 |
| 55 | Cornerstone Research Institute | Orlando | Florida | United States | 32822 |
| 56 | Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | United States | 32174 |
| 57 | Sunset Point Medical Associates | Palm Harbor | Florida | United States | 34684 |
| 58 | Radiant Research | Pinellas Park | Florida | United States | 33781 |
| 59 | St. Johns Center for Clinical Research | Ponte Vedra | Florida | United States | 32081 |
| 60 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
| 61 | Health Awareness | Port Saint Lucie | Florida | United States | 34952 |
| 62 | Precision Clinical Research | Sunrise | Florida | United States | 33351 |
| 63 | GCP Clinical Research, LLC | Tampa | Florida | United States | 33614 |
| 64 | Premier Medical Associates | The Villages | Florida | United States | 32159 |
| 65 | Clinical Research of Central Florida | Winter Haven | Florida | United States | 33880 |
| 66 | Agile Clinical Research Trials, LLC | Atlanta | Georgia | United States | 30328 |
| 67 | iResearch Atlanta LLC | Decatur | Georgia | United States | 30030 |
| 68 | NuDirections Clinical Research | Duluth | Georgia | United States | 30096 |
| 69 | Infinite Clinical Trials | Riverdale | Georgia | United States | 30274 |
| 70 | WR-Mount Vernon Clinical Research | Sandy Springs | Georgia | United States | 30328 |
| 71 | Georgia Clinical Research | Snellville | Georgia | United States | 30078 |
| 72 | Rosemark Women Care Specialists | Idaho Falls | Idaho | United States | 83404 |
| 73 | The Healing Sanctuary, LLC | Idaho Falls | Idaho | United States | 83404 |
| 74 | Womens Health USA, Inc. | Champaign | Illinois | United States | 61820 |
| 75 | Affinity Clinical Research Institute | Oak Brook | Illinois | United States | 60523 |
| 76 | Investigators Research Group, Llc | Brownsburg | Indiana | United States | 46254 |
| 77 | MediSphere Medical Research | Evansville | Indiana | United States | 47714 |
| 78 | Cypress Medical Research Center | Wichita | Kansas | United States | 67226 |
| 79 | Avant Research Associates, LLC | Crowley | Louisiana | United States | 70526 |
| 80 | Praetorian Pharmaceutical Research | Marrero | Louisiana | United States | 70072 |
| 81 | Southern Clinical Research Associates | Metairie | Louisiana | United States | 70001 |
| 82 | Medpharmics, LLC | Metairie | Louisiana | United States | 70006 |
| 83 | Pharmasite Research Inc | Baltimore | Maryland | United States | 21208 |
| 84 | Bay State Clinical Trials, Inc. | Watertown | Massachusetts | United States | 02472 |
| 85 | Saginaw Valley Medical Research Group, Llc | Saginaw | Michigan | United States | 48604 |
| 86 | Montana Medical Research Inc | Missoula | Montana | United States | 59801 |
| 87 | Quality Clinical Research, Inc | Omaha | Nebraska | United States | 68114 |
| 88 | Clinical Research Center of Nevada (CRCN) | Las Vegas | Nevada | United States | 89104-3218 |
| 89 | Excel Clinical Research, LLC | Las Vegas | Nevada | United States | 89109 |
| 90 | Office Of Edmond Pack, Md | Las Vegas | Nevada | United States | 89113 |
| 91 | Dr.R. Garn Mabey, MD,Office Of | Las Vegas | Nevada | United States | 89128 |
| 92 | Hassman Research Institute, LLC | Berlin | New Jersey | United States | 08009 |
| 93 | Lawrence OBGYN Associates | Lawrenceville | New Jersey | United States | 08648 |
| 94 | Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | United States | 87102 |
| 95 | Bosque Women's Care | Albuquerque | New Mexico | United States | 87109-4640 |
| 96 | Rochester Clinical Research, Inc. | Rochester | New York | United States | 14609 |
| 97 | Circuit Clinical | West Seneca | New York | United States | 14224 |
| 98 | Upstate Clinical Research Associates LLC | Williamsville | New York | United States | 14221 |
| 99 | OnSite Clinical Solutions, LLC | Charlotte | North Carolina | United States | 28277 |
| 100 | Carolina women's research and wellness center | Durham | North Carolina | United States | 27714 |
| 101 | Carolina Insitute for Clinical Research | Fayetteville | North Carolina | United States | 28304 |
| 102 | Unified Women's Clinical Research | Greensboro | North Carolina | United States | 27408 |
| 103 | PMG Research of Hickory, LLC | Hickory | North Carolina | United States | 28601 |
| 104 | Unified Women's Clinical Research | Raleigh | North Carolina | United States | 27607 |
| 105 | Wake Research Associates, LLC | Raleigh | North Carolina | United States | 27612 |
| 106 | Unified Women's Clinical Research | Winston-Salem | North Carolina | United States | 27103 |
| 107 | Lillestol Research, LLC | Fargo | North Dakota | United States | 58104 |
| 108 | CTI | Cincinnati | Ohio | United States | 45227 |
| 109 | Greater Cincinnati OB/GYN | Cincinnati | Ohio | United States | 45267 |
| 110 | Aventiv Research, Inc. | Columbus | Ohio | United States | 43213 |
| 111 | Complete Healthcare For Women | Columbus | Ohio | United States | 43231 |
| 112 | Hwc Women's Research Center | Englewood | Ohio | United States | 45322 |
| 113 | Neuro-Behavioral Clinical Research, Inc | North Canton | Ohio | United States | 44720 |
| 114 | OB-GYN Associates | Erie | Pennsylvania | United States | 16507 |
| 115 | The Clinical Trial Center LLC | Jenkintown | Pennsylvania | United States | 19046 |
| 116 | Philadelphia Clinical Research, LLC | Philadelphia | Pennsylvania | United States | 19114 |
| 117 | Frontier Clinical Research | Smithfield | Pennsylvania | United States | 15478 |
| 118 | Clinical Trials of South Carolina | Charleston | South Carolina | United States | 29406 |
| 119 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
| 120 | Chattanooga GYN-Oncology | Chattanooga | Tennessee | United States | 37404 |
| 121 | WR Clinsearch, LLC | Chattanooga | Tennessee | United States | 37421 |
| 122 | Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | United States | 38119 |
| 123 | Medical Research Center of Memphis, LLC | Memphis | Tennessee | United States | 38120 |
| 124 | International Clinical Research | Murfreesboro | Tennessee | United States | 37130 |
| 125 | Tekton Research - Georgetown | Austin | Texas | United States | 78745 |
| 126 | Gadolin Research, LLC | Beaumont | Texas | United States | 77702 |
| 127 | DiscoveResarch, Inc. | Bryan | Texas | United States | 77802 |
| 128 | Advances in Health | Houston | Texas | United States | 77030 |
| 129 | Centex Studies, Inc. | Houston | Texas | United States | 77058 |
| 130 | Protenium Clinical Research, LLC | Hurst | Texas | United States | 76054 |
| 131 | FMC Science | Lampasas | Texas | United States | 76550 |
| 132 | ClinRx Research | Plano | Texas | United States | 75024 |
| 133 | Clinical Trials of Texas | San Antonio | Texas | United States | 78229 |
| 134 | Northeast Clinical Research Centers, Inc. | Schertz | Texas | United States | 78154 |
| 135 | Excel Clinical Research, LLC | Sugar Land | Texas | United States | 77478 |
| 136 | EPIC Medical Research | Murray | Utah | United States | 84123 |
| 137 | Advanced Clinical Research-Old Farm OB/GYN (Utah) | Salt Lake City | Utah | United States | 84107 |
| 138 | Wasatch Clinical Research, LLC | Salt Lake City | Utah | United States | 84107 |
| 139 | Charlottesville Medical Research | Charlottesville | Virginia | United States | 22911 |
| 140 | Health Research of Hampton Roads Inc | Newport News | Virginia | United States | 23606 |
| 141 | Tidewater Clinical Research, Inc. | Virginia Beach | Virginia | United States | 23456 |
| 142 | Seattle Women's: Health, Research, Gynecology | Seattle | Washington | United States | 98115 |
| 143 | Site CA15005 | Brampton | Ontario | Canada | L6T 0G1 |
| 144 | Site CA15006 | Burlington | Ontario | Canada | L7M 4Y1 |
| 145 | Site CA15010 | Sarnia | Ontario | Canada | N7T 4X3 |
| 146 | Site CA15007 | Toronto | Ontario | Canada | M9W 4L6 |
| 147 | Site CA15012 | Levis | Quebec | Canada | |
| 148 | Site CA15004 | Point Claire | Quebec | Canada | H9R 4S3 |
| 149 | Site CA15003 | Sherbrooke | Quebec | Canada | J1L 0H8 |
| 150 | Site CA15001 | Victoriaville | Quebec | Canada | G6P 6P6 |
| 151 | Site CA15002 | Quebec | Canada | G1N 4V3 | |
| 152 | Site CA15009 | Quebec | Canada | G1W 4R4 | |
| 153 | Site CZ42008 | Vodnany | Jihocesky | Czechia | 389 01 |
| 154 | Site CZ42001 | Olomouc | Czechia | 772 00 | |
| 155 | Site CZ42003 | Olomouc | Czechia | 779 00 | |
| 156 | Site CZ42010 | Pisek | Czechia | 39701 | |
| 157 | Site CZ42009 | Praha 2 | Czechia | 12000 | |
| 158 | Site CZ42005 | Tabor 3 | Czechia | 39003 | |
| 159 | Site LV37102 | Riga | Latvia | 1005 | |
| 160 | Site LV37101 | Riga | Latvia | 1010 | |
| 161 | Site PL48004 | Bialystok | Poland | 15-224 | |
| 162 | Site PL48005 | Bydgoszcz | Poland | 85-065 | |
| 163 | Site PL48002 | Katowice | Poland | 40-611 | |
| 164 | Site PL48019 | Katowice | Poland | 40-851 | |
| 165 | Site PL48006 | Lublin | Poland | 20-069 | |
| 166 | Site PL48014 | Lublin | Poland | 20362 | |
| 167 | Site PL48016 | Poznan | Poland | 60-192 | |
| 168 | Site PL48010 | Szczecin | Poland | 71-434 | |
| 169 | Site PL48020 | Warsaw | Poland | 02-201 | |
| 170 | Site PL48003 | Warszawa | Poland | 02-798 | |
| 171 | Site PL48007 | Warszawa | Poland | 02777 | |
| 172 | Site ES34005 | Centelles | Spain | 08540 | |
| 173 | Site ES34002 | Madrid | Spain | 28041 | |
| 174 | Site UA38004 | Zaporizhzhya | Zaporizka Oblast | Ukraine | 69065 |
| 175 | Site UA38006 | Kiev | Ukraine | ||
| 176 | Site GB44003 | Wokingham | Berkshire | United Kingdom | RG40 1XS |
| 177 | Site GB44008 | Sidcup | Kent | United Kingdom | DA146LT |
| 178 | Site GB44005 | Corby | Northamptonshire | United Kingdom | NN17 2UR |
| 179 | Site GB44004 | Kenilworth | Warwickshire | United Kingdom | CV8 1JD |
| 180 | Site GB44006 | Middlesex | United Kingdom | HA6 2RN | |
| 181 | Site GB44007 | Romford | United Kingdom | ||
| 182 | Site GB44001 | Shipley | United Kingdom | BD18 3SA |
Sponsors and Collaborators
- Astellas Pharma Global Development, Inc.
Investigators
- Study Director: Executive Medical Director, Astellas Pharma Global Development, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2693-CL-0304
- 2019-000275-16