A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel group,Multicentre Study Investigating the Efficacy and Safety of Sepranolone (UC1010) in Patients with PMDD
This study is recruiting participants with severe premenstrual symptoms that may fit the diagnosis of premenstrual dysphoric disorder (PMDD). The aim of this study is to investigate the effect of Sepranolone given during three consecutive menstrual cycles (during the luteal phase only) on premenstrual symptoms and evaluate the safety of this potential new medication for PMDD.
The effect on symptoms will be evaluated using a questionnaire; you will be asked to report your symptoms using an electronic patient diary. There are 3 treatment groups; two groups with different doses of Sepranolone and a placebo (dummy medication without any active ingredients) group. You will not know which treatment group you have been assigned to; however you will have a 2:1 chance of receiving Sepranolone.