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

November 12, 2021 updated by: Sojournix, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Sojournix Site #202
      • Genk, Belgium
        • Sojournix Site #204
      • Ghent, Belgium
        • Sojournix Site #201
  • Germany
      • Berlin, Germany
        • Sojournix Site #308
      • Berlin, Germany
        • Sojournix Site #309
      • Bernburg, Germany
        • Sojournix Site #304
      • Hamburg, Germany
        • Sojournix Site #301
      • Hamburg, Germany
        • Sojournix Site #306
      • Marburg, Germany
        • Sojournix Site #305
  • Poland
      • Białystok, Poland
        • Sojournix Site #401
      • Katowice, Poland
        • Sojournix Site #402
      • Lublin, Poland
        • Sojournix Site #403
      • Lublin, Poland
        • Sojournix Site #404
      • Lublin, Poland
        • Sojournix Site #405
      • Łódź, Poland
        • Sojournix Site #406
  • United Kingdom
      • Blackpool, United Kingdom
        • Sojournix Site #108
      • Cannock, United Kingdom
        • Sojournix Site #111
      • Glasgow, United Kingdom
        • Sojournix Site #104
      • Leeds, United Kingdom
        • Sojournix Site #112
      • Liverpool, United Kingdom
        • Sojournix Site #110
      • London, United Kingdom
        • Sojournix Site #105
      • Manchester, United Kingdom
        • Sojournix Site #107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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. 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.
  6. 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.
  7. Have an endometrial thickness ≤4 mm by transvaginal ultrasound at Screening.
  8. Be willing to undergo an endometrial biopsy if they have unexplained bleeding during the study or 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.

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 positive 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. 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.
  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 (eg, narcolepsy, sleep apnea, restless leg syndrome).
  6. 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).
  7. Have any abnormal liver function tests at Screening or an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (CKD-EPI 2009 calculation; Levey et al 2009).
  8. Have tested positive for human immunodeficiency virus, hepatitis B, C or E at Screening.
  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.
  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. Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, based on the median of a total of 4 to 6 readings, from 2 to 3 readings taken on 2 different occasions.
  14. Have clinically significant abnormal ECG or QT interval prolongation (corrected for heart rate using Fridericia formula [QTcF] prolongation >470 ms) at Screening.
  15. Have a history of endometrial hyperplasia or uterine/endometrial cancer.
  16. Have current unexplained uterine bleeding.
  17. Have a history of cancer prior to Screening (other than local, treated basal cell or squamous cell carcinoma).
  18. 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.
  19. Are pregnant or lactating.
  20. Have used hormonal treatments within defined periods of time prior to the start of the Run-in Period. Washout times dependent on treatment.
  21. Are taking any nonhormonal medication for treatment of VMS in the 8-week period prior to the start of the Run-in Period.
  22. 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.
  23. Are taking any antiestrogens, selective estrogen receptor modulators, or aromatase inhibitors.
  24. Are taking any antigonadotropin medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive placebo
Drug: Placebo
administered orally once daily
Experimental: SJX-653
Participants will receive SJX-653
Drug: SJX-653
administered orally once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Average Daily Frequency of Moderate to Severe Vasomotor Symptoms (VMS) From Baseline to Week 4
Time Frame: Baseline to Week 4
Moderate to severe vasomotor symptoms collected daily by e-diary
Baseline to Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean Change in the Severity of Moderate to Severe VMS From Baseline to Week 4
Time Frame: Baseline to Week 4
Baseline to Week 4
Mean Change and Percent Change of Parameters of VMS Frequency and Severity by Study Week
Time Frame: Baseline up to Week 6
Baseline up to Week 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in Insomnia Severity Index (ISI)
Time Frame: Baseline up to Week 4
Baseline up to Week 4
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS)
Time Frame: Baseline up to Week 4
Baseline up to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sojournix, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Sojournix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJX-653-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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