A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
Primary Purpose
Premenstrual Dysphoric Disorder
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
UC1010
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Dysphoric Disorder
Eligibility Criteria
Inclusion Criteria:
Part 1 -Essentially healthy
Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles
Exclusion Criteria:
- 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
Sites / Locations
- Umecrine Mood AB
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
UC1010 low dose
UC1010 high dose
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Premenstrual symptom severity
Secondary Outcome Measures
Number of subjects with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01875718
Brief Title
A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umecrine Mood AB
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Dysphoric Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UC1010 low dose
Arm Type
Active Comparator
Arm Title
UC1010 high dose
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
UC1010
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Premenstrual symptom severity
Time Frame
Daily Record of Severity of Problems (DRSP) measured during 4-5 months
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events
Time Frame
During 1.5 month (starting from first dose)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Eligibility Criteria
Inclusion Criteria:
Part 1 -Essentially healthy
Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles
Exclusion Criteria:
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
Facility Information:
Facility Name
Umecrine Mood AB
City
Solna
ZIP/Postal Code
17165
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
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