The impact of steroid hormones on symptom provocation in patients with premenstrual dysphoric disorder

INTERVENTION: Trade Name: Enanton Depot Product Name: leuprorelin acetate Pharmaceutical Form: Solution for injection INN or Proposed INN: Leuproreline acetat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3,75‐ Trade Name: Enanton Depot Product Name: leuprorelin acetate Pharmaceutical Form: Solution for injection INN or Proposed INN: Leuproreline acetat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 11,25‐ Trade Name: Divigel Product Name: Divigel Pharmaceutical Form: Gel INN or Proposed INN: estradiolhemihydrat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1,0‐ Pharmaceutical form of the placebo: Gel Route of administration of the placebo: Cutaneous use Trade Name: Divigel Product Name: Divigel Pharmaceutical Form: Gel INN or Proposed INN: estradiolhemihydrat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0,5‐ Product Name: Progesterone Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Progesteronum mikroniserad, Ph Eur Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Pharmaceutical form of the placebo: Vaginal tablet Route of administration of the placebo: Vaginal use CONDITION: Premenstrual Dysphoric Disorder PRIMARY OUTCOME: Main Objective: To evaluate the effect of different doses (1,5 mg vs 0,5 mg) of estradiol (in combination with progesterone) on symptom provocation.; ; To evaluate whether estradiol 1,5 mg is more symptom provocating in combination with progesterone compared to in combination with placebo. Primary end point(s): Daily ratings on the "Cyclicity Diagnoser" rating scales during the last 14 days of each treatment cycle. ; Symptoms rated include: depression, diminished interest in usual activities, irritability, anxiety/tension, mood swings, disordered sleep, food cravings, feeling of being out of control, breast tension, energy, concentration, fatigue, bloating, cheerfulness, effect on daily life, and menstrual bleeding. Secondary Objective: INCLUSION CRITERIA: 1. Diagnosed premenstrual dysphoric disorder 2. Age between 18 and 45 years 3. Regular menstrual cycles (between 25 ‐ 31 days) 4. Informed consent 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range