A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
NCT ID: NCT01875718
Last Updated: 2015-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
146 participants
INTERVENTIONAL
2013-01-31
2014-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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UC1010 low dose
UC1010
UC1010 high dose
UC1010
Vehicle
Placebo
Interventions
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UC1010
Placebo
Eligibility Criteria
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Inclusion Criteria
Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Umecrine Mood AB
INDUSTRY
Responsible Party
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Locations
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Umecrine Mood AB
Solna, , Sweden
Countries
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Other Identifiers
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UM104
Identifier Type: -
Identifier Source: org_study_id
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