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

Sojournix, Inc0 sites130 target enrollmentOctober 30, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Sojournix, Inc
Enrollment: 130
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 30, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Sojournix, Inc

Eligibility Criteria

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.

Exclusion Criteria

•Subjects are to be excluded from the study if they meet any of the following 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.