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Phase 2 Study of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278872
Recruitment Status : Suspended (Temporarily halted due to COVID-19)
First Posted : February 20, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Sojournix, Inc.

Brief Summary:
This study evaluates the efficacy, safety, tolerability, and pharmacokinetics of two doses of once daily SJX-653 in postmenopausal women with moderate to severe VMS.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: SJX-653 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: SJX-653 Dose 1
Participants will receive Dose 1 of SJX-653
Drug: SJX-653
administered orally once daily

Experimental: SJX-653 Dose 2
Participants will receive Dose 2 of SJX-653
Drug: SJX-653
administered orally once daily

Placebo Comparator: Placebo
Participants will receive placebo
Drug: Placebo
administered orally once daily




Primary Outcome Measures :
  1. Mean change in average daily frequency of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Mean change in the frequency of moderate to severe VMS from baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  2. Mean change in the severity of moderate to severe VMS from baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  3. Mean change in the severity of moderate to severe VMS from baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
  4. Mean change and percent change of parameters of VMS frequency and severity. [ Time Frame: Baseline up to Week 12 ]
  5. Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline up to Week 12 ]
  6. Change from Baseline in Insomnia Severity Index (ISI) [ Time Frame: Baseline up to Week 12 ]
  7. Change from Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) [ Time Frame: Baseline up to Week 12 ]
  8. Change from Baseline in Menopause-Specific Quality of Life (MENQoL) questionnaire [ Time Frame: Baseline up to Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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:

    1. Spontaneous amenorrhea for at least 12 months, OR
    2. 6 months of spontaneous amenorrhea with serum FSH levels >40 milli-International unit (mIU/mL), OR
    3. 6 weeks past a postsurgical bilateral oophorectomy with or without hysterectomy.

    All postmenopausal woman (PMW) must have a serum follicle stimulating hormone (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:

    1. Mild: Sensation of heat without sweating/damping; if at night, do not wake up but later notice damp sheets or clothing.
    2. 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.
    3. 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.

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 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 ≥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 within defined periods of time prior to the start of the Run-in Period. Washout times dependent on treatment.
  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, or aromatase inhibitors.
  23. Are taking any antigonadotropin medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278872


Locations
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United Kingdom
Sojournix Site #102
Aberdeen, United Kingdom
Sojournix Site #104
Glasgow, United Kingdom
Sojournix Site #105
London, United Kingdom
Sponsors and Collaborators
Sojournix, Inc.
Investigators
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Study Director: Medical Director Sojournix, Inc.
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Responsible Party: Sojournix, Inc.
ClinicalTrials.gov Identifier: NCT04278872    
Other Study ID Numbers: SJX-653-006
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms