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Clinical Trials/EUCTR2019-002281-12-DE
EUCTR2019-002281-12-DE
Active, not recruiting
Phase 1

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 sites66 target enrollmentOctober 31, 2019
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Sojournix, Inc
Enrollment
66
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 31, 2019
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

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

  • •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 \+ve 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 with the following exceptions:
  • •\-SSRIs and 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.
  • •\-SSRIs and SNRIs for treatment of VMS are prohibited
  • •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.

Outcomes

Primary Outcomes

Not specified

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