jRCT2031230584进行中（未招募）不适用
A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Investigate the Long Term Safety of Fezolinetant in Japanese Women Experiencing Vasomotor Symptoms (Hot Flashes) Associated with Menopause (Starlight 3)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 277
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 40age old over 至 65age old under（—）
入选标准
- •Participant confirmed as menopausal per one of the following criteria at the screening visit (visit 1):
- •For a post-menopausal participant:
- •o Spontaneous amenorrhea for >= 12 consecutive months;
- •o Spontaneous amenorrhea for >= 6 months with biochemical criteria of menopause (follicle-stimulating hormone [FSH] > 40 IU/L);
- •o Having had bilateral oophorectomy >= 6 weeks prior to the screening visit (visit 1) (with or without hysterectomy);
- •o Having had hysterectomy without bilateral oophorectomy with the biochemical criteria of menopause (FSH > 40 IU/L); or
- •o Having been confirmed to be post-menopausal in the 2693-CL-0310 study.
- •For a peri-menopausal participant:
- •o Spontaneous amenorrhea for >= 60 days but < 6 consecutive months 2 times in the 2 most recent menstrual cycles with biochemical criteria of peri-menopause (FSH > 25 IU/L); or
- •o Spontaneous amenorrhea for >= 6 months but < 12 consecutive months with biochemical criteria of peri-menopause (FSH > 25 IU/L and <= 40 IU/L).
- •o Having had hysterectomy without bilateral oophorectomy with the biochemical criteria of peri-menopause (FSH > 25 IU/L and <= 40 IU/L)
- •Participant is seeking treatment for relief of vasomotor symptoms (VMS) associated with menopause.
- •Female participant:
- •Is not pregnant and at least 1 of the following conditions apply:
- •a. Not a women of childbearing potential (WOCBP)
- •b. WOCBP who has a negative urine pregnancy test day 1 (visit 2) and agrees to follow the contraceptive guidance from the time of informed consent through at least 21 days after final study intervention administration.
- •Must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 21 days after final study intervention administration.
- •Must not donate ova starting at first administration of study intervention and throughout the investigational period and for 21 days after final study intervention administration.
- •Participant agrees not to participate in another interventional study while participating in the present study.
排除标准
- •Participant has a history of an undiagnosed uterine bleeding within the 6 months prior to the screening visit (visit 1).
- •Participant has a current malignant tumor or history (except for a participant who has not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence) of a malignant tumor except for non-metastatic basal cell carcinoma of the skin.
- •Participant 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) that could confound interpretation of the study outcome.
- •Participant uses a prohibited therapy (hormone therapy, hormone replacement therapy [HRT], hormonal contraceptive, any treatment for VMS [prescription medications, over-the-counter, or herbal/Kampo medicines] or strong or moderate cytochrome P450 1A2 [CYP1A2] inhibitors) and is not willing to wash out or discontinue use of such drugs from screening visit (visit 1) through the follow-up visit (visit 16) or it is not medically appropriate to discontinue such drugs for the duration of the study.
- •Participant has been randomized/registered in a clinical trial with fezolinetant previously or had previous exposure to marketed fezolinetant elsewhere.
- •Participant has a present or previous history of participation in this study.
- •Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening visit (visit 1).
- •Participant has an unacceptable result from the transvaginal ultrasound (TVU) assessment at screening (i.e., full length of endometrial cavity cannot be visualized or presence of clinically significant abnormal findings).
- •Participant has documentation of a clinically significant abnormal Papanicolaou (Pap) test (or equivalent cervical cytology) within 12 months prior to the screening visit (visit 1) or at screening.
- •Participant has active liver disease, jaundice, or elevated liver aminotransferases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]), elevated total bilirubin (TBL) or direct bilirubin (DBL), elevated international normalized ratio (INR), or elevated alkaline phosphatase (ALP) at screening. A participant with mildly elevated ALT or AST up to < 1.5 x upper limit of normal (ULN) can be enrolled if TBL and DBL are normal. Participant 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. Participant with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal.
- •Participant has creatinine > 1.5 x ULN or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula <= 30 mL/min/1.73 m^2 at screening.
- •Participant has positive hepatitis serology panel (i.e., positive hepatitis B surface [HBs] antigen and/or positive hepatitis C virus [HCV] antibody) at screening. If HCV antibody test result is equivocal, hepatitis C virus ribonucleic acid (HCV RNA) test at study site is allowed. Participant can be enrolled if that result is normal or not abnormal.
- •Participant is not in good general health as determined on the basis of medical history and general physical examination performed at the screening; hematology parameters, biochemistry parameters, pulse rate, blood pressure, electrocardiogram (ECG) outside the reference range for the population studied, or is showing clinically relevant deviations.
- •Participant has a history of suicide attempt or suicidal behavior within 12 months prior to study enrollment or suicidal ideation within 12 months prior to study enrollment (a response of "yes" to question 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale [C-SSRS]), or is at significant risk to commit suicide at day 1 (visit 2).
- •Participant is unable or unwilling to complete the study procedures.
- •Participant has any condition which makes the participant unsuitable for study participation.
- •Participant has a known or suspected hypersensitivity to fezolinetant or any components of the formulation used.
- •Participant is the investigator or a member of the study site staff.
- •Participant is an employee of Astellas, the study-related contract research organizations (CROs) or site management organizations.
结局指标
主要结局
-
Frequency and severity of Adverse Events (AEs)
次要结局
- Mean change from baseline in endometrial thickness(52 weeks)
- Clinical laboratory tests
- Vital signs
- Plasma concentrations of fezolinetant and metabolite ES259564(scheduled time points)
研究者
相似试验
未知
2 期
OSKIRA-Asia-1XRheumatoid ArthritisJPRN-jRCT2080221945AstraZeneca
招募中
2 期
A observational study for safety and efficacy of Fulvestrant 500mg in postmenopausal patients with ER positive advanced or recurrent breast cancer after prior endocrine treatment. (SBCCSG-29)ocally advanced or metastatic breast cancerJPRN-UMIN000009110Saitama Breast Cancer Clinical Study Group(SBCCSG)100
已完成
不适用
Safety confirmation test of long-term intake of foods containing Camellia Japonica seed extractHealthy adultJPRN-UMIN000038877Oneness support Co., Ltd.20
已完成
不适用
A clinical study for evaluating safety of long-term consumption -Non-blind, safety verification study taking 1 times dose of test food "KW-01" in healthy adults.Healthy adultsJPRN-UMIN000025376Kowa Company, Ltd.10
进行中（未招募）
1 期
Exploratory study of the efficacy and safety of flexible doses of Milnacipran and Venlafaxine administered in out patients with Major Depressive Disorder.MedDRA version: 8.1 Level: LLT Classification code 10012378 Term: DepressionMajor Depressive DisorderEUCTR2006-003658-47-FRPierre Fabre Médicament - IRPF180