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: 19 Sep 2015

At a glance

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

    • 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.
    • 10 Apr 2014 According to the ClinicalTrials.gov record, planned end date changed from 1 Mar 2014 to 1 May 2014.
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