A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2

Phase 3

Completed

Conditions: Hot Flashes

Interventions: Drug: Fezolinetant
Drug: placebo

Registration Number: NCT04003142

Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary: This study was for women in menopause with moderate to severe 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 study treatments are fezolinetant 30 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 is a dummy treatment that looks like medicine but does not have any medicine in it.) The study compared fezolinetant and placebo after 4 and 12 weeks of dosing. The study evaluated if fezolinetant reduces the number of hot flashes and the study evaluated if fezolinetant reduces the severity of the hot flashes.

Women in the study received an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants used this to record their hot flashes. Their record for the 10 days before the start of study treatment was checked. They remained in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they were picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin.

The study participants took study treatment for 52 weeks. The first 12 weeks of study treatment 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) during that time. The last 40 weeks of study treatment was "noncontrolled." That means that each study participant and the study doctors knew which study treatment that study participant took during that time. Women who took fezolinetant during the first 12 weeks continued to take the same dose. Women who took placebo during the first 12 weeks took fezolinetant. Their dose was either 30 mg or 45 mg fezolinetant.

At weeks 2, 4, 8, 12, 14, 16 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 was collected for laboratory tests. Study participants completed questionnaires that were about how hot flashes affect their daily life. Study participants who had their uterus had the following 2 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. This test used sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which was placed inside the vagina. Study participants might 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 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 agrees.

The last check-up at the hospital or clinic was 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 501

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 [FSH] > 40 IU/L); or
- Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit.
Within the 10 days prior to randomization, subject must have a minimum average of 7 to 8 moderate to severe hot flashes (HFs) vasomotor symptoms (VMS) per day, or 50 to 60 per week.
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 electrocardiogram (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 findings mammogram (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), and for subjects who are withdrawn from the study prior to completion, a TVU at the early discontinuation (ED) visit.
Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT), for subjects with uterine bleeding, and for subjects who are withdrawn from the study prior to completion. 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 1A2 [CYP1A2] inhibitors, hormone replacement therapy [HRT], hormonal contraceptive or any treatment for VMS [prescription, over the counter or herbal]) or is not willing to wash out and discontinue use of such drugs for the full duration of study conduct.
Subject has 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 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 × ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula ≤ 59 mL/min per 1.73 m^2 at screening.
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 question 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 at screening and at 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 partial or full hysterectomy.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg	Fezolinetant	Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.
Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg	Fezolinetant	Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg orally, QD from week 13 up to Week 52 during extension treatment period.
Double-blind Period: Placebo	placebo	Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.
Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg	Fezolinetant	Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.
Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg	Fezolinetant	Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4	Baseline and week 4	Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.
Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4	Baseline and week 4	The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.
Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12	Baseline and week 12	The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.
Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12	Baseline and week 12	Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12	Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, and 11	The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12	Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12	The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization. Participant has \>=50% reduction from baseline to each post baseline week for the frequency of moderate to severe VMS.
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12	Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12	The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization. Participant has 100% reduction from baseline to each post baseline week for the frequency of moderate to severe VMS.
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit	Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52 of fezolinetant exposure (weeks 16, 24, 28, 32, 36, 40, 44, 48 and 52 for arms Placebo/Fezolinetant 30 mg and Placebo/Fezolinetant 45 mg)	The PGI is comprised of 2 companion 1-item PRO measures analogous to the Clinical Global Impression (CGI) scales. These measures provide brief, stand-alone global assessments prior to and after initiating a study medication. Patient-perceived change from the initiation of treatment (PGI-C)-VMS is used to evaluate meaningful within-person changes over time in VMS. This measure provides patient-perceived change from the initiation of treatment. The PGI-C VMS asks: "Compared to the beginning of this study, how would you rate your HFs/night sweats now?" Subject ratings range from (1) much better to (7) much worse. Participant ratings range from 1=much better, 2= moderately better, 3= a little better, 4= no change, 5= a little worse, 6= moderately worse, 7= much worse.
Change From Baseline in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) Total Score at Week 12	Baseline and week 12	The PROMIS SD SF 8b assesses self-reported sleep disturbance over the past 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Because it assesses the participants experience of sleep disturbance, the measure does not focus on specific sleep-disorder symptoms or ask participants to report objective measures of sleep (e.g., total amount of sleep, time to fall asleep and amount of wakefulness during sleep). Responses to each of the 8 items range from 1 (no disturbed sleep) to 5 (disturbed sleep), and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the disturbed sleep.
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS at Week 24	Baseline and 24 weeks of fezolinetant exposure (week 36 for arms Placebo/Fezolinetant 30 mg and Placebo/Fezolinetant 45 mg)	The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12	Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11	Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.
Number of Participants With Adverse Events	From first dose date up to 21 days after last dose (up to 55 weeks)	An AE is any untoward medical occurrence in a participant administered a study drug, \& which does not necessarily have to have a causal relationship with treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with use of a medicinal product (mp) whether or not considered related to the mp. An AE is considered "serious" if it results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Results in congenital anomaly or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization, hospitalization for treatment/observation/examination caused by AE is to be considered as serious, discontinuation due to increases in liver enzymes, other medically important events. TEAE was defined as an AE observed from first dose date up to 21 days after last dose.
Mean Percent Change in The Frequency of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week Up to Week 12	Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12	The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.
Change From Baseline in The Mean Severity of Moderate, and Severe VMS at Week 24	Baseline and 24 weeks of fezolinetant exposure (week 36 for arms Placebo/Fezolinetant 30 mg and Placebo/Fezolinetant 45 mg)	Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.

Trial Locations

Locations (93): Comprehensive Clinical Development
🇺🇸
West Palm Beach, Florida, United States
Hwc Women's Research Center
🇺🇸
Englewood, Ohio, United States
Site CA15002
🇨🇦
Sherbrooke, Quebec, Canada
Site PL48011
🇵🇱
Krakow, Poland
Site PL48010
🇵🇱
Warsaw, Poland
Site LV37101
🇱🇻
Riga, Latvia
Wake Research Associates, LLC
🇺🇸
San Diego, California, United States
LCC Medical Research Institute, LLC
🇺🇸
Miami, Florida, United States
Clinical Research Center of Nevada (CRCN)
🇺🇸
Las Vegas, Nevada, United States
Dr.R. Garn Mabey, MD,Office Of
🇺🇸
Las Vegas, Nevada, United States
Centex Studies, Inc.
🇺🇸
Houston, Texas, United States
Wasatch Clinical Research, LLC
🇺🇸
Salt Lake City, Utah, United States
Seattle Women's: Health, Research, Gynecology
🇺🇸
Seattle, Washington, United States
Precision Trials
🇺🇸
Phoenix, Arizona, United States
Site LV37103
🇱🇻
Riga, Latvia
Mesa Obstetricians and Gynecologists
🇺🇸
Mesa, Arizona, United States
Excell Research
🇺🇸
Oceanside, California, United States
Women's Healthcare Affiliates
🇺🇸
San Diego, California, United States
Nature Coast Clinical Research
🇺🇸
Crystal River, Florida, United States
Site PL48013
🇵🇱
Elblag, Poland
ClinRx Research
🇺🇸
Plano, Texas, United States
Site PL48001
🇵🇱
Bydgoszcz, Poland
Site CZ42007
🇨🇿
Pisek, Czechia
Site CZ42005
🇨🇿
Tabor 3, Czechia
Site CZ42003
🇨🇿
Vsetin, Czechia
Georgia Research for Women
🇺🇸
Atlanta, Georgia, United States
Site CA15008
🇨🇦
Quebec, Canada
Site CZ42006
🇨🇿
Praha 2, Czechia
Site CZ42004
🇨🇿
Praha 9, Czechia
Bioclinica Research
🇺🇸
Orlando, Florida, United States
Hassman Research Institute, LLC
🇺🇸
Berlin, New Jersey, United States
Site CA15006
🇨🇦
Sarnia, Ontario, Canada
Site PL48002
🇵🇱
Lublin, Poland
Site PL48003
🇵🇱
Warszawa, Poland
Site PL48012
🇵🇱
Lublin, Poland
Site PL48005
🇵🇱
Szczecin, Poland
Site ES34001
🇪🇸
Madrid, Spain
Site PL48004
🇵🇱
Piaseczno, Poland
Site PL48006
🇵🇱
Poznan, Poland
Site ES34003
🇪🇸
Aravaca, Spain
Site GB44001
🇬🇧
Shipley, United Kingdom
Downtown Women's Health Care
🇺🇸
Denver, Colorado, United States
Horizons Clincial Research Center LLC
🇺🇸
Denver, Colorado, United States
Site ES34002
🇪🇸
Centelles, Spain
Agile Clinical Research Trials, LLC
🇺🇸
Atlanta, Georgia, United States
Suncoast Research
🇺🇸
Miami, Florida, United States
Visions Clinical Research - Tuscon
🇺🇸
Tucson, Arizona, United States
Clinical Trials Research
🇺🇸
Sacramento, California, United States
Dream Team Clinical Research, LLC
🇺🇸
Pomona, California, United States
Bayview Research Group
🇺🇸
Valley Village, California, United States
Bioclinica Research, Melbourne
🇺🇸
Melbourne, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸
Miami, Florida, United States
Medical Health Center & Research
🇺🇸
Miami, Florida, United States
Meridien Research
🇺🇸
Saint Petersburg, Florida, United States
Sensible Healthcare LLC
🇺🇸
Ocoee, Florida, United States
Healthcare Clinical Data Inc
🇺🇸
North Miami, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸
Ormond Beach, Florida, United States
WR-Mount Vernon Clinical Research
🇺🇸
Sandy Springs, Georgia, United States
iResearch Atlanta LLC
🇺🇸
Decatur, Georgia, United States
Elite Clinical Trials
🇺🇸
Blackfoot, Idaho, United States
Affinity Clinical Research Institute
🇺🇸
Oak Brook, Illinois, United States
ASR, LLC-Advanced Specialty Research
🇺🇸
Nampa, Idaho, United States
Cypress Medical Research Center
🇺🇸
Wichita, Kansas, United States
Women Under Study, LLC
🇺🇸
New Orleans, Louisiana, United States
Bosque Women's Care
🇺🇸
Albuquerque, New Mexico, United States
Pharmasite Research Inc
🇺🇸
Baltimore, Maryland, United States
Albuquerque Clinical Trials, Inc.
🇺🇸
Albuquerque, New Mexico, United States
Circuit Clinical
🇺🇸
West Seneca, New York, United States
Premier Gynecology & Wellness
🇺🇸
Charlotte, North Carolina, United States
OB/GYN Associates of Erie
🇺🇸
Erie, Pennsylvania, United States
Dr. Marvin Kalafer MD, Office Of
🇺🇸
Jenkintown, Pennsylvania, United States
Medication Management, LLC
🇺🇸
Greensboro, North Carolina, United States
Clinical Neuroscience Solutions, Inc
🇺🇸
Memphis, Tennessee, United States
The Clinical Research Center, LLC
🇺🇸
Carrollton, Texas, United States
Advances in Health
🇺🇸
Houston, Texas, United States
Granger Medical Clinic
🇺🇸
Riverton, Utah, United States
North Spokane Women's Health
🇺🇸
Spokane, Washington, United States
Site CA15009
🇨🇦
Toronto, Ontario, Canada
Site CA15007
🇨🇦
Levis, Quebec, Canada
Helix Biomedics
🇺🇸
Boynton Beach, Florida, United States
Research Protocol Management Specialists
🇺🇸
Pittsburgh, Pennsylvania, United States
Renaissance Research and Medical Group, Inc.
🇺🇸
Cape Coral, Florida, United States
GCP Clinical Research, LLC
🇺🇸
Tampa, Florida, United States
Physicians' Research Options/Red Rocks OB/GYN
🇺🇸
Lakewood, Colorado, United States
Progressive Medical Research
🇺🇸
Port Orange, Florida, United States
Physician Care Clinical Research, LLC
🇺🇸
Sarasota, Florida, United States
Southern Clinical Research Associates
🇺🇸
Metairie, Louisiana, United States
Georgia Clinical Research
🇺🇸
Snellville, Georgia, United States
Site CA15001
🇨🇦
Victoriaville, Quebec, Canada
Praetorian Pharmaceutical Research
🇺🇸
Marrero, Louisiana, United States
Site PL48009
🇵🇱
Katowice, Poland
FMC Science
🇺🇸
Lampasas, Texas, United States
Clinical Research of Central Florida
🇺🇸
Winter Haven, Florida, United States