Trial to Assess the Safety of Fezolinetant in Women Suffering from Hot Flashes Associated with Menopause
- Conditions
- Vasomotor Symptoms (Hot Flashes) Associated with MenopauseMedDRA version: 21.0Level: LLTClassification code 10020407Term: Hot flashesSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2019-000275-16-CZ
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1740
1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures.
2. Subject is born female, aged = 40 years and = 65 years of age at the screening visit.
3. Subject has a body mass index between =18 kg/m2 and = 38 kg/m2.
4. Subject must be seeking treatment or relief for 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 (FSH > 40 IU/L), or
? Having had bilateral oophorectomy = 6 weeks prior to the screening visit.
5. Subject is seeking treatment for relief for VMS associated with menopause.
6. 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, as judged by the investigator.
7. Subject has documentation of a normal/negative or no clinically significant mammogram findings (obtained at screening or within the prior 12 months of trial enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.
8. Subject is willing to undergo a TVU to evaluate the uterus and ovaries at screening and at week 52 (EOT). For subjects who are withdrawn
from the study prior to completion, a TVU should be collected at the ED visit.
9. 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.
10. Subject has documentation of a normal or not clinically significant Pap test (or equivalent cervical cytology) in the opinion of the investigator within the previous 12 months or at screening.
11. Subject has a negative urine pregnancy test at screening.
12. 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.
13. Subject agrees not to participate in another interventional study while participating in the present study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1740
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Subject uses a prohibited therapy (strong or moderate CYP1A2 inhibitors, 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.
2. Subject has a known substance abuse or alcohol addiction within 6 months of screening, as assessed by investigator.
3. Subject has previous or current history of a malignant tumor, except for basal cell carcinoma.
4. Subject´s systolic blood pressure is = 130 mmHg or diastolic blood pressure is = 80 mmHg based on an average of 2 to 3 readings on at least 2 different occasions within the screening period.
Subjects who do not meet the criteria may, at the discretion of the investigator, be re-assessed after initiation or review of antihypertensive measures.
Subjects with a medical history or hypertension can be enrolled at the discretion of the Investigator once they are medically cleared (stable and compliant)
5. Subject has a history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.
6. 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.
7. Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer or other clinically significant findings in the opinion of the investigator at screening.
8. Subject has a history within the last 6 months of undiagnosed uterine bleeding.
9. Subject has a history of seizures or other convulsive disorders.
10. 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 in the opinion of the investigator.
11. Subject has active liver disease, jaundice, elevated liver aminotransferases (ALT or AST), elevated total or direct bilirubin (DBL), 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 DBL are normal. Patients with mildly elevated ALP (up to < 1.5 × 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 TBL may be enrolled as long as DBL,
hemoglobin, and reticulocytes are normal.
12. Subject has creatinine > 1.5 × ULN; or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula = 59 mL/min per 1.73 m2 at the screening visit.
13. 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 by the investigator at screening and at the time of visit 2 (randomization).
14. Subject has had a partial or full hysterectomy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method