Status:
COMPLETED
A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
Lead Sponsor:
Umecrine Mood AB
Conditions:
Premenstrual Dysphoric Disorder
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- Part 1 -Essentially healthy
- Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles
Exclusion
- steroid hormonal treatment during the previous three months
- treatment with psychopharmaceuticals or other treatment for PMS
- history of or a significant medical condition ongoing
- be pregnant or plan a pregnancy within the study period
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01875718
Start Date
January 1 2013
End Date
June 1 2014
Last Update
January 21 2015
Active Locations (1)
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1
Umecrine Mood AB
Solna, Sweden, 17165