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: 01 Jun 2017
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At a glance
- Drugs Sepranolone (Primary)
- Indications Premenstrual dysphoric disorder
- Focus First in man; Pharmacokinetics; Therapeutic Use
- Sponsors Asarina Pharma; Umecrine Mood
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History