The effect of SJX-653 on Menopausal Hot Flushes
- Conditions
- Treatment of moderate to severe vasomotor symptoms (VMS) associatedwith menopause.MedDRA version: 21.1Level: LLTClassification code 10027311Term: Menopause flushingSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2019-002281-12-GB
- Lead Sponsor
- Sojournix, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 66
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of oral SJX-653 on moderate to severe VMS symptom frequency after 4 weeks of treatment. ;Secondary Objective: Secondary:<br>• Efficacy of oral SJX-653 on measures of VMS severity and frequency.<br>• Safety and tolerability of SJX-653.<br>• PK of SJX-653.;Primary end point(s): Mean change in average daily frequency of moderate to severe VMS from Baseline to Week 4. <br>;Timepoint(s) of evaluation of this end point: Baseline to Week 4.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy<br>• Mean change and percent change of parameters of VMS frequency and severity<br>Safety<br>• Change in clinical laboratory, vital signs, and ECGs<br>Pharmacokinetic<br>• Estimation of SJX-653 PK profile;Timepoint(s) of evaluation of this end point: Baseline to Week 4