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

Conditions: Premenstrual Dysphoric Disorder

Registration Number: EUCTR2004-004516-22-SE

Lead Sponsor: ppsala University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 30

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

Exclusion Criteria

1. Pregnant or breastfeeding
2. Use of oral contraceptives, progestagens, antiandrogens or any other hormones during the last 6 months.
3. Use of antidepressants, benozodiazepines or any other compound with central nervous system effects during the last 2 months.
4. Personal or family history of thromboembolism.
5. High blod pressure (>145/90)
6. Ongoing psychiatric disorder according to M.I.N.I. structured psychiatric interview.
7. Report of physical or psychological violence by the patient.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>To evaluate whether estradiol 1,5 mg is more symptom provocating in combination with progesterone compared to in combination with placebo. ;Secondary Objective: ;Primary end point(s): Daily ratings on the Cyclicity Diagnoser rating scales during the last 14 days of each treatment cycle. <br>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 Outcome Measures