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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History