A study to evaluate UC1010 dose versus exposure and dose versus effect on PMS symptoms in patients with PMDD (severe premenstrual depression and anxiety) - a phase I/II study
- Conditions
- Premenstrual Dysphoric Disorder (PMDD)Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2012-004081-18-SE
- Lead Sponsor
- mecrine Mood AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
For part 1, the subjects must:
-be essentially healthy
For part 2, the subjects must:
-have PMDD according to DSM-IVa verified in two menstrual cycles
In addition, the subjects must:
-be a woman between 18-45 years of age
-have a regular menstrual cycle
-use barrier contraception or non-hormonal IUD, be abstinent or surgically sterilized
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 146
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects must not:
-have or have had any steroid hormonal treatment during the previous three months
-have or have had treatment with psychopharmaceuticals during the previous month
-have a history of or have a significant medical condition ongoing, including any psychiatric disease
-have a history of or have a drug or alcohol abuse or use more than 30 g of alcohol per day
-be pregnant or plan a pregnancy within the study period
-participate concurrently in any other clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the pharmacokinetic properties of subcutaneously administered UC1010 and the pharmacodynamic effect of UC1010 in women with PMDD ;Secondary Objective: The secondary objectives are to investigate the safety and tolerability of subcutaneously administered UC1010;Primary end point(s): Study part 1: Plasma concentrations of the IMP<br>Study part 2: Symptom assessment using a validated daily rating scale (DRSP) containing the demanded symptoms in DSM-IV for diagnosis of PMDD ;Timepoint(s) of evaluation of this end point: Study part 1: Up to 72 hours after single injection<br>Study part 2: During one menstrual cycle of treatment and during one menstrual cycle of non-treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Physical examinations, inspection of injection sites, safety blood sampling and AE reporting<br>;Timepoint(s) of evaluation of this end point: During and up to one month after treatment.