NCT05419908已完成2 期
Pilot/Phase IIa Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
Ogeda S.A.8 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2015年9月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 8
- 主要终点
- Change From Baseline to Week 12 in The Weekly General Hot Flash Score
研究概览
简要总结
The primary purpose of this study was to evaluate the effect of ESN364 on the severity and frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms of changes in weekly Hot Flash Score from baseline to Week 12.
This study also evaluated the effect of ESN364 on the severity and frequency of hot flashes at additional timepoints; hot flash interference on daily life, in terms of changes from baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale (SDS); pharmacodynamic (PD) effect; and safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Spontaneous amenorrhea for at least 12 consecutive months; or spontaneous amenorrhea for at least 6 months with biochemical criteria of menopause (FSH >40 IU/L); or spontaneous amenorrhea for at least 3 months with biochemical/physical criteria of menopause (FSH >40 IU/L and E2 <0.21 nmol/); or having had bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy);
- •At least 49 moderate or severe hot flashes or night sweats over a period of 7 consecutive days, as recorded in the daily diary during the screening period, with at least 4 of those days with 7 or more moderate or severe hot flashes per day;
- •In good general health as determined on the basis of medical history and general physical examination performed at screening; hematology and chemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations;
- •Negative urine test for selected drugs of abuse (amphetamines, tricyclic antidepressants, cannabinoids, cocaine, tetrahydrocannabinol, or opiates) at screening;
- •Negative serology panel (including hepatitis B surface antigen [HBsAg], antihepatitis C virus [HCV] and human immunodeficiency virus (HIV) antibody screens);
- •Negative urine pregnancy test at screening;
排除标准
- •Use of a prohibited therapy or not willing to wash-out drugs considered prohibited therapies;
- •History (in the past year) or presence of drug or alcohol abuse;
- •Suicide attempt in the past 3 years;
- •Previous or current history of a malignant tumor (except basal cell carcinoma);
- •Active liver disease or jaundice, or out-of-range values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST); or total bilirubin >1.3 times the upper limit of normal (ULN); or creatinine >1.5 times the ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula <60 mL/min/1.73 m2 at screening;
- •Medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], or endocrine disease) or malignancy that could confound interpretation of the study outcome;
- •Any psychological disorder according to the criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders (DSM, 4th edition) within one year prior to screening. Such disorders include but are not limited to current major depression, alcohol (more than 3 glasses of wine, beer, or equivalent/day) or substance abuse/dependence;
- •Unsuited to participate in the study, based on findings observed during physical examination, vital sign assessment, or 12-lead ECG;
- •History of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients;
- •Presence or sequellae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution, metabolism, or excretion (ADME) mechanisms of drugs;
- •Concurrent participation in another interventional study (or participation within 3 months prior to screening in this study);
- •History of poor compliance in clinical studies;
- •Unable or unwilling to complete the study procedures;
- •Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
研究组 & 干预措施
Fezolinetant
Experimental
Participants received 90 milligrams (mg) fezolinetant capsules orally, twice daily (BID) for a period of 12 weeks
干预措施: Fezolinetant (Drug)
Placebo
Placebo Comparator
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in The Weekly General Hot Flash Score
时间窗: Baseline and week 12
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant dependent for both number and severity.
次要结局
- Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)(Baseline and weeks 4, 8 and 12)
- Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)(Baseline and weeks 4, 8 and 12)
- Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive)(Baseline and weeks 4, 8 and 12)
- Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Plasma Concentration of Leptin(Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15))
- Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG)(Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15))
- Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Plasma Concentration of Estradiol (E2)(Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15))
- Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH)(Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15))
- Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH)(Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12: 3h, follow-up (week 15))
- Change From Baseline in Plasma Concentration of Insulin(Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15))
- Number of Participants With Adverse Events (AE's)(From first dose of study drug until end of the study (Up to week 15))
- Change From Baseline in Plasma Concentration of C-peptide(Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15))
- Change From Baseline in Plasma Concentration of Bone Alkaline Phosphatase (BALP) at Week 12(Baseline and week 12)
- Change From Baseline in Plasma Concentration of Glycated Hemoglobin (HBA1c)(Baseline and week 12)
- Change From Baseline in Plasma Concentration of Carboxy-terminal Telopeptide of Type I Collagen (CTX) at Week 12(Baseline and week 12)
研究者
研究点 (8)
Loading locations...
相似试验
招募中
1 期
Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)Ileal PouchNCT05938465Exegi Pharma, LLC50
招募中
2 期
Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac SurgeryCardiac Surgery Associated - Acute Kidney InjuryNCT06632613EnnovaBio200
尚未招募
早期 1 期
Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's LymphomaLymphoma, Non-Hodgkin's, AdultNCT05979857Salarius Pharmaceuticals, LLC72
已完成
1 期
A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic FunctionHepatic ImpairmentHealthy VolunteersNCT04942964Astellas Pharma Global Development, Inc.25
终止
2 期
A Phase II Study of Dacomitinib in Progressive Brain MetastasesBrain CancerNCT02047747David Piccioni, M.D., Ph.D4