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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004516-22-SE

Enrollment

Registered

2004-11-25

Start date

2005-02-01

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Dysphoric Disorder

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. ;Secondary Objective: ;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.	—

Measure

Time frame

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. ;Secondary Objective: ;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.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026