A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
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.