The effect of SJX-653 on Menopausal Hot Flashes

Phase 1

Conditions: Treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
MedDRA version: 21.1Level: LLTClassification code 10027311Term: Menopause flushingSystem Organ Class: 100000004872
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2019-002281-12-ES

Lead Sponsor: Sojournix, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 0

Inclusion Criteria

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 documentation (written or electronic report) of a negative mammogram at Screening or within 12 months before Screening, and a normal clinical breast examination at Screening.
6. Have documentation (written or electronic report) of a normal Pap smear (or equivalent cervical cytology), or a Pap smear of no clinical significance in the opinion of the Investigator, at Screening or within 12 months before Screening.
7. Have an endometrial thickness =4 mm by transvaginal ultrasound at Screening.
8. Be willing to undergo an endometrial biopsy at Screening and at Week 12 (EOT) in the event that the subject's transvaginal ultrasound shows endometrial thickness >4 mm.
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 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Subjects are to be excluded from the study if they meet any of the following criteria:
1.Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator or have any medical condition that requires chronic medication and that in the Investigator’s opinion, would make subjects unsuitable for participation in the study.
2.Have a history of diagnosis of major depressive disorder in the 3 years prior to Screening, or are on any antidepressant, anxiolytic or antipsychotic treatment. Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) treatment for mild depression and/or mild anxiety is allowed provided medication is stable and well-tolerated in the 3 months prior to the Screening Visit and does not change during study participation.
3. Have a history of suicide ideation or attempt in the past 3 years.
4. Have a history of a sleep disorder other than insomnia due to VMS (eg, narcolepsy, sleep apnea, restless leg syndrome).
5. Have clinical or biochemical evidence of active hepatitis or other significant hepatic or biliary disease (eg, chronic hepatitis, cirrhosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, nonalcoholic steatohepatitis, nonalcoholic fatty liver disease, or hereditary liver disease).
6. Have any abnormal liver function tests a Screening or an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (CKD-EPI 2009 calculation; Levey et al 2009).
7. Have tested positive for human immunodeficiency virus, hepatitis B, C or E at Screening.
8. 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
9. Have a history of alcohol abuse or a history of substance abuse.
10. Smoking >10 cigarettes per day.
11. Regularly working night shifts.
12. Systolic blood pressure =140 mmHg and/or diastolic blood pressure as =90 mmHg, based on the average of 2 to 3 readings on at least 2 different occasions.
13. Have clinically significant abnormal ECG or QT interval prolongation (corrected for heart rate using Fridericia formula [QTcF] prolongation >470 ms) at Screening.
14. Have a history of endometrial hyperplasia or uterine/endometrial cancer.
15. Have current unexplained uterine bleeding.
16. Have a history of cancer prior to Screening (other than local, treated basal cell or squamous cell carcinoma).
17. Have any significant illness requiring hospitalization or emergency treatment within 4 weeks prior to the Screening Visit or during the Screening or Run-in Periods, and as determined by the Investigator.
18. Are pregnant or lactating.
19. Have used hormonal treatments prior to the start of the Run-in Period
20. Are taking any nonhormonal medication for treatment of VMS in the 8-week period prior to the start of the Run-in Period
21. Have used herbal supplements or over-the-counter (OTC) medications for treatment of VMS 8 weeks prior to the start of the Run-in Period. Any other herbal supplements or OTC supplements that could interfere with the study objectives require a 28-day wash-out period prior to the start of the Run-in Period.
22. Are taking any antiestrogens, selective estrogen receptor modulators,

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 12 weeks of treatment.;Secondary Objective: Secondary:<br>• Efficacy of oral SJX-653 on measures of VMS severity and frequency.<br>• Impact of oral SJX-653 on measures of sleep.<br>• Impact of oral SJX-653 on measures of QoL.<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 12.;Timepoint(s) of evaluation of this end point: Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Baseline to Week 12;Secondary end point(s): Efficacy <br>• Mean change and percent change of parameters of VMS frequency and severity<br>• Change in sleep scores<br><br>Quality of Life<br>• Change in Quality of Life scores<br><br>Safety<br>Change in clinical laboratory, vital signs, and ECGs.<br><br>Pharmacokinetic<br>Estimation of SJX-653 PK profile

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