Premenstrual Dysphoric Disorder (PMDD)
Conditions
Interventions
Product Name: isoallopregnanolone
Product Code: UC1010
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: ISOALLOPREGNANOLONE
CAS Number: 516-55-2
Concentration unit: mg/ml milligram(s
Sponsors
Umecrine Mood AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 Study part 2: During one menstrual cycle of treatment and during one menstrual cycle of non-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Physical examinations, inspection of injection sites, safety blood sampling and AE reporting ;Timepoint(s) of evaluation of this end point: During and up to one month after treatment. | — |
Countries
Sweden
Contacts
Public ContactDepartment of Clinical Trials
Umecrine Mood AB
Outcome results
None listed