Clinical Trial: A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women
Brief Summary:
The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1.
In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group.
Detailed Summary:
Sponsor: Umecrine Mood AB
Current Primary Outcome: Premenstrual symptom severity [ Time Frame: Daily Record of Severity of Problems (DRSP) measured during 4-5 months ]
Original Primary Outcome: Premenstrual symptom severity [ Time Frame: DRSP measured daily during 4-5 months ]
Current Secondary Outcome: Number of subjects with adverse events [ Time Frame: During 1.5 month (starting from first dose) ]
Original Secondary Outcome: Same as current
Information By: Umecrine Mood AB
Dates:
Date Received: May 29, 2013
Date Started: January 2013
Date Completion:
Last Updated: January 19, 2015
Last Verified: January 2015
