EUCTR2019-002281-12-GB进行中（未招募）1 期
A phase 2, prospective, randomized, double-blind, placebo-controlled clinical study to assess the efficacy, safety, tolerability, and pharmacokinetics of SJX-653 in postmenopausal women with moderate to severe vasomotor symptoms - Effect of SJX-653 on Moderate to Severe Hot Flushes due to Menopause
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Subjects must meet the following criteria for inclusion:
- •1. Signed a consent form before Screening procedures begin.
- •2. Be a postmenopausal female, 40 to 65 years of age (inclusive) at the Screening Visit, defined as:
- •a.Spontaneous amenorrhea for at least 12 months, OR
- •b.6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL, OR
- •c.6 weeks past a postsurgical bilateral oophorectomy with or without hysterectomy,
- •All PMW must have a serum FSH >40 mIU/mL at Screening.
- •3. Have an average of at least 7 moderate to severe VMS per day at Baseline
- •The following definitions for severity are used:
- •a.Mild: Sensation of heat without sweating/ damping; if at night, do not wake up but later notice damp sheets or clothing.
- •b.Moderate: Sensation of heat with sweating/dampness, but able to continue activity; if at night, wake up because hot and/or sweating, but no action is necessary other than rearranging the bed sheets.
- •c.Severe: Sensation of heat with sweating causing disruption of current activity; if at night, wake up hot and sweating and need to take action (eg, removing layer of clothes, open the window, or get out of bed).
- •4. Have a body mass index between 18 and 35 kg/m2, inclusive.
- •5. Have a clinical breast exam without clinically significant finding at Screening.
- •6. For Subjects 50-65 years old, have documentation (written or electronic report) of a satisfactory mammogram result at Screening within applicable intervals stated in local breast cancer screening guidelines. Subjects 40-49 years old require a mammogram within the same intervals.
- •7. Have documentation (written or electronic report) of a normal Pap smear (or equivalent cervical cytology) in combination with Human
- •Papilloma virus (HPV) testing, or a Pap smear of no clinical significance in the opinion of the Investigator, at Screening within applicable
- •intervals stated in local cervical cancer prevention guidelines.
- •8. Be willing to undergo a transvaginal ultrasound to assess endometrial thickness at Screening and at Week 4 (EOT). This is not required for subjects who have had a partial (supracervical) or full hysterectomy.
- •9. Have an endometrial thickness =4 mm by transvaginal ultrasound at Screening.
- •10. Subjects must be willing to undergo an endometrial biopsy if they have unexplained bleeding during the study or an endometrial thickness >4 mm at the EOT Visit. An endometrial biopsy is not required for
- •subjects who have had a partial (supracervical) or full hysterectomy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Have clinically significant history or evidence of poorly controlled
- •cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or have any other medical condition that, in the Investigator's opinion, would make subjects unsuitable for participation in the study.
- •2. Have manifest or suspected active COVID-19 infection:
- •- Have tested +ve for SARS-CoV-2 based on a RT-PCR or other validated test, or
- •- Have clinical symptoms suggestive of COVID-19 infection, or
- •- Have to comply with quarantine requirements per local Public Health directive
- •3. A history of diagnosis of major depressive disorder in the 3 years prior to Screening, or are on antidepressant, anxiolytic or antipsychotic treatment with the following exception:
- •- SSRIs and SNRIs treatment for mild depression and/or mild anxiety are allowed provided medication is stable and well-tolerated in the 3 months prior to the Screening Visit and does not change during study participation.
- •- SSRIs and SNRIs for treatment of VMS are prohibited.
- •4. Have a history of suicide ideation or attempt in the past 3 years.
- •5. Have a sleep disorder other than insomnia due to VMS.
- •6. Have clinical or biochemical evidence of active hepatitis or other significant hepatic or biliary disease.
- •7. Have abnormal liver function test laboratory values at Screening or
- •Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (CKDEPI 2009 calculation; Levey 2009).
- •8. Have tested positive for HIV antigen or antibodies, hepatitis B,C or E.
- •9. Have any gastrointestinal, liver, kidney or other disorder that would significantly interfere with the absorption, distribution, metabolism, or excretion (ADME) of drugs in the opinion of the Investigator, including
- •surgery (eg, short bowel syndrome, gastric or intestinal bypass surgery).
- •10. Have a history of alcohol abuse or a history of substance abuse.
- •11. Smoking >10 cigarettes per day.
- •12. Regularly working night shifts.
- •13. Have a history of hypersensitivity to more than two chemical classes of drugs, or known hypersensitivity to SJX-653 or any of its excipients.
- •14. Systolic blood pressure =140 mmHg and/or diastolic blood pressure as =90 mmHg, based on the median of a total of 4 to 6 readings, from 2 to 3 readings taken on 2 different occasions.
- •15. Have poorly controlled Type II diabetes mellitus as defined by a glycosylated hemoglobin (HbA1c) >8.0% despite standard care.
- •Subjects with Type I diabetes and subjects on insulin treatment are excluded.
- •16. Have a history of or are on treatment for hyperthyroidism or hypothyroidism, or have abnormal thyroid tests at Screening. Subjects
- •with subclinical hypothyroidism, and subjects on stable treatment for hypothyroidism for a least 3 months prior to Screening with normal
- •thyroid function test results at Screening are allowed.
- •17. Have clinically significant abnormal ECG or QT interval prolongation at Screening.
- •18. Have a history of endometrial hyperplasia or uterine/endometrial cancer.
- •19. Have current unexplained uterine bleeding.
- •20. Have a history of cancer prior to Screening (other than local, treated basal cell or squamous cell carcinoma).
- •21. Have any significant illness requiring hospitalization or emergency
- •treatment within 4 weeks prior to the Screening Visit or during the Screening Period, as determined by the Investigator.
- •22. Are pregnant or lactating.
- •23. Are taking any drugs considered moderate or s
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