NCT01875718

A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Umecrine Mood AB · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

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.

Conditions

• Premenstrual Dysphoric Disorder

Interventions

Type	Name	Description
DRUG	UC1010
DRUG	Placebo

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-06-12
• Last updated: 2015-01-21

Locations

1 site across 1 country: Sweden