A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
- Registration Number
- NCT01875718
- Lead Sponsor
- Umecrine Mood AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 146
Part 1 -Essentially healthy
Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UC1010 low dose UC1010 - UC1010 high dose UC1010 - Vehicle Placebo -
- Primary Outcome Measures
Name Time Method Premenstrual symptom severity Daily Record of Severity of Problems (DRSP) measured during 4-5 months
- Secondary Outcome Measures
Name Time Method Number of subjects with adverse events During 1.5 month (starting from first dose)
Trial Locations
- Locations (1)
Umecrine Mood AB
🇸🇪Solna, Sweden