Phase 2 Study of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms (NCT04278872) | Clinical Trial Compass
TerminatedPhase 2
Phase 2 Study of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
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
Belgium, Germany13 participantsStarted 2020-11-09
Plain-language summary
This study evaluates the efficacy, safety, tolerability, and pharmacokinetics of once daily SJX-653 in postmenopausal women with moderate to severe VMS.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Mean Change in Average Daily Frequency of Moderate to Severe Vasomotor Symptoms (VMS) From Baseline to Week 4
✕. 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).
✕. 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.