Hot FlashesPhase 2NCT04278872
Phase 2 Study of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
A Phase 2 study testing SJX-653 in people with Hot Flashes, run by Sojournix, Inc. at 22 sites in 4 countries.
Trial summary
This study evaluates the efficacy, safety, tolerability, and pharmacokinetics of once daily SJX-653 in postmenopausal women with moderate to severe VMS. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- SJX-653
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 9 Nov 2020to 7 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed a consent form before Screening procedures begin.
- Be a postmenopausal female, 40 to 65 years of age (inclusive) at the Screening Visit, defined as:
- Spontaneous amenorrhea for at least 12 months, OR
- 6 months of spontaneous amenorrhea with serum FSH levels >40 milli-International unit (mIU/mL), OR
- 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.
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- Have an average of at least 7 moderate to severe VMS per day at Baseline. The following definitions for severity are used:
- Mild: Sensation of heat without sweating/damping; if at night, do not wake up but later notice damp sheets or clothing.
- 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.
- 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).
- Have a body mass index between 18 and 35 kg/m2, inclusive.
- 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.
- 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.
- Have an endometrial thickness ≤4 mm by transvaginal ultrasound at Screening.
- 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.
Who cannot join
- 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.
- 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.
- 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.
- Have a history of suicide ideation or attempt in the past 3 years.
- Have a history of a sleep disorder other than insomnia due to VMS (eg, narcolepsy, sleep apnea, restless leg syndrome).
- 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).
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- 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).
- Have tested positive for human immunodeficiency virus, hepatitis B, C or E at Screening.
- 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.
- Have a history of alcohol abuse or a history of substance abuse.
- Smoking >10 cigarettes per day.
- Regularly working night shifts.
- 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.
- Have clinically significant abnormal ECG or QT interval prolongation (corrected for heart rate using Fridericia formula [QTcF] prolongation >470 ms) at Screening.
- Have a history of endometrial hyperplasia or uterine/endometrial cancer.
- Have current unexplained uterine bleeding.
- Have a history of cancer prior to Screening (other than local, treated basal cell or squamous cell carcinoma).
- 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.
- Are pregnant or lactating.
- Have used hormonal treatments within defined periods of time prior to the start of the Run-in Period. Washout times dependent on treatment.
- Are taking any nonhormonal medication for treatment of VMS in the 8-week period prior to the start of the Run-in Period.
- 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.
- Are taking any antiestrogens, selective estrogen receptor modulators, or aromatase inhibitors.
- Are taking any antigonadotropin medication.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United Kingdom7 sites
Sojournix Site #108
Blackpool
Sojournix Site #111
Cannock
Sojournix Site #104
Glasgow
Sojournix Site #112
Leeds
Sojournix Site #110
Liverpool
Sojournix Site #105
London
Sojournix Site #107
Manchester
Germany6 sites
Sojournix Site #308
Berlin
Sojournix Site #309
Berlin
Sojournix Site #304
Bernburg
Sojournix Site #301
Hamburg
Sojournix Site #306
Hamburg
Sojournix Site #305
Marburg
Poland6 sites
Sojournix Site #401
Bialystok
Sojournix Site #402
Katowice
Sojournix Site #406
Lodz
Sojournix Site #403
Lublin
Sojournix Site #404
Lublin
Sojournix Site #405
Lublin
Belgium3 sites
Sojournix Site #202
Brussels
Sojournix Site #204
Genk
Sojournix Site #201
Ghent
About this study
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
This study evaluates the efficacy, safety, tolerability, and pharmacokinetics of once daily SJX-653 in postmenopausal women with moderate to severe VMS.
- Conditions
- Hot Flashes
- Being tested
- SJX-653, Placebo
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJX-653Drug
administered orally once daily
PlaceboDrug
administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| SJX-653 | Experimental | Participants will receive SJX-653 Receives: Drug: SJX-653 |
| Placebo | Placebo comparator | Participants will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Average Daily Frequency of Moderate to Severe Vasomotor Symptoms (VMS) From Baseline to Week 4
Moderate to severe vasomotor symptoms collected daily by e-diary
Measured: Baseline to Week 4
Secondary outcomes (2)
Mean Change in the Severity of Moderate to Severe VMS From Baseline to Week 4
Measured: Baseline to Week 4
Mean Change and Percent Change of Parameters of VMS Frequency and Severity by Study Week
Measured: Baseline up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start9 Nov 2020
- Primary completion12 Feb 2021
- Study completion7 Apr 2021
Why it stopped: The study was terminated early as the goal of determining a safe and efficacious dose for further development for the treatment of VMS was not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sojournix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sojournix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278872
- Sponsor's protocol ID
- SJX-653-006
- Status last verified
- Nov 2021
- First submitted
- 18 Feb 2020
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04278872
- Acronym / sponsor ID
- SJX-653-006
- Conditions
- Hot Flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early as the goal of determining a safe and efficacious dose for further development for the treatment of VMS was not met
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sojournix, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy, safety, tolerability, and pharmacokinetics of once daily SJX-653 in postmenopausal women with moderate to severe VMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SJX-653 | Experimental | Drug: SJX-653Participants will receive SJX-653 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed a consent form before Screening procedures begin.
- Be a postmenopausal female, 40 to 65 years of age (inclusive) at the Screening Visit, defined as:
- All postmenopausal woman (PMW) must have a serum follicle stimulating hormone (FSH) >40 mIU/mL at Screening.
- Have an average of at least 7 moderate to severe VMS per day at Baseline. The following definitions for severity are used:
- Have a body mass index between 18 and 35 kg/m2, inclusive.
Key exclusion criteria (24 listed)
- 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.
- 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.
- 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.
- Have a history of suicide ideation or attempt in the past 3 years.
- Have a history of a sleep disorder other than insomnia due to VMS (eg, narcolepsy, sleep apnea, restless leg syndrome).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SJX-653administered orally once daily | Drug | SJX-653 |
| Placeboadministered orally once daily | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Mean Change in the Severity of Moderate to Severe VMS From Baseline to Week 4
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sojournix, Inc.
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SJX-653 in people with Hot Flashes, run by Sojournix, Inc. at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Germany, Poland, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Average Daily Frequency of Moderate to Severe Vasomotor Symptoms (VMS) From Baseline to Week 4 (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.