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 - Effect of SJX-653 on Moderate to Severe Hot Flushes due to Menopause

Sojournix, Inc.0 sites66 target enrollmentSeptember 20, 2019

Overview

No summary available.

Registry

who.int

Start Date

September 20, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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.

•1\. Have clinically significant history or evidence of poorly controlled
•cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or have any other medical condition 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 \+ve for 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\. A history of diagnosis of major depressive disorder in the 3 years prior to Screening, or are on antidepressant, anxiolytic or antipsychotic treatment with the following exception:
•\- SSRIs and SNRIs treatment for mild depression and/or mild anxiety are allowed provided medication is stable and well\-tolerated in the 3 months prior to the Screening Visit and does not change during study participation.
•\- SSRIs and SNRIs for treatment of VMS are prohibited.
•4\. Have a history of suicide ideation or attempt in the past 3 years.