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-DE
• Lead Sponsor: Sojournix, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-31
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 66

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 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:
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

Exclusion 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 manifest or suspected active COVID-19 infection
-Have tested +ve for presence of 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.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 with the following exceptions:
-SSRIs and 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.
-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 history of 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 any abnormal liver function tests a Screening or an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2).
8. Have tested positive for human immunodeficiency virus, 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 at least 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 (T3, T4, thyroid-stimulating hormone) 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 or Run-in Periods, and as determined by the Investigator.
22. Are p

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified