A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study

Trial Profile

A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study

Completed
Phase of Trial: Phase I/II

Latest Information Update: 01 Jun 2017

At a glance

  • Drugs Sepranolone (Primary)
  • Indications Premenstrual dysphoric disorder
  • Focus First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Asarina Pharma; Umecrine Mood
  • Most Recent Events

    • 01 Jun 2017 Secondary outcome measures also included, Negative mood score i.e. the ratings of the 4 key symptoms in PMDD(anger/irritability, depression, anxiety and lability) and impairment (impact on daily life), according to results published in the Psychoneuroendocrinology Journal.
    • 19 Sep 2015 Primary endpoint [Symptom assessment using a validated daily rating scale (DRSP) containing the demanded symptoms in DSM-IV for diagnosis of PMDD (Premenstrual symptom severity] has not been met.
    • 26 Jul 2014 Status changed from active, no longer recruiting to completed, as per European Clinical Trials Database record.
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