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

INTERVENTION: 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)/millilitre Concentration type: up to Concentration number: 40‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use CONDITION: Premenstrual Dysphoric Disorder (PMDD) Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: To investigate the pharmacokinetic properties of subcutaneously administered UC1010 and the pharmacodynamic effect of UC1010 in women with PMDD 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 Secondary Objective: The secondary objectives are to investigate the safety and tolerability of subcutaneously administered UC1010 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 OUTCOME: 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. 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