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Negative outcome in PMDD study

Umecrine’s drug candidate for PMDD treatment did not show any effect compared to placebo according to the results from a phase II study.

In an exploratory double blind, randomized multicenter study, 120 patients with PMDD received, during one menstrual cycle, either placebo or one of two different doses of the drug candidate UC1010, a GABA-A modulating steroid antagonist (GAMSA). The objectives of the trial were to study the safety and effect of UC1010. The primary end point in the study was to assess symptoms using a validated daily rating scale (DRSP) containing the sum of the four cardinal symptoms for diagnosis of PMDD measured as the average score during the late luteal phase (the premenstrual week) in the active dose arms combined vs. placebo.

The outcome of the study shows a reduction in the average late luteal phase score after treatment vs. before treatment of 61% in the active group and 55% in the placebo group. The difference between the active group and placebo was not statistically significant and the primary end-point of the study was thus not met. In a post hoc analysis there was a statistically significant difference (p<0.05) between active treatment and placebo in patients with severe problems during a week or more per cycle. Moreover, differences were observed in the PMDD symptoms that are clinically most relevant. There were no safety concerns with UC1010 and it was well tolerated.