Effects of allopregnanolone in women with PMDD, depression, PCOS och oral contraceptives

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002540-94-SE

Enrollment

Registered

2004-10-01

Start date

2004-11-25

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

PMDD (premenstrual dysphoric disorder) includes depressed mood and anxiety but occurs only during the late phase of the menstrual cycle. Major depression are more common in women and especially post partum and during the menopause. PCOS (polycystic ovary syndrome) include symptoms like hirsutism, amenorrhoea and obesity but depressive symptom also occur. Mental side effects from oral contraceptives are common.

Interventions

Product Name: Allopregnanolone Product Code: UC1009 Pharmaceutical Form: Injection* CAS Number: 516-54-1 Current Sponsor code: UC1009 Other descriptive name: Allopregnanolone Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Group 1: Women 18-40 years of age with PMDD. 2. Group 2: Women 18-40 years of age with depression. 3. Group 3: Women 18-40 years of age with PCOS and increased weight. 4. Group 4: Women 18-40 years of age with oral contraceptives. 5. Group 5: healthy women 18-40 years of age without hormonal treatment. 6. Written 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Treatment with bensodiazepins or other psychotropic drugs. 2. Treatment with systemic glucocorticoids. 3. Group 1, 2, 3, 5: Hormonal treatment of any kind during the last six months. 4. Group 1: Psychiatric disease or PCOS. 5. Group2: PMDD or PCOS. 6. Group 3: Psychiatric disease or PMDD. 7. Group 4, 5: Psychiatric disease, PMDD or PCOS. 8. Ongoing severe somatic disease. 9. Obesity. 10. Alcohol or drug abuse. 11. Eye disease with compromise measurement of saccadic eye movements.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the sensitivity to allopregnanolone (a GABA-agonistic neurosteroid), in different phases of the menstrual cycle, in women with PMDD, depression, PCOS and oral contraceptives compared to healthy controls without homonal treatment. To measure subjective ratings of mood symtoms and alertness in the same groups of women. ;Secondary Objective: To measure side effects.;Primary end point(s): Changes in saccadic eye movement velocity compared to pre-treatment. Changes in subjective ratings of sedation and mood symptoms compared to pre-treatment.	—

Measure

Time frame

Main Objective: To investigate the sensitivity to allopregnanolone (a GABA-agonistic neurosteroid), in different phases of the menstrual cycle, in women with PMDD, depression, PCOS and oral contraceptives compared to healthy controls without homonal treatment. To measure subjective ratings of mood symtoms and alertness in the same groups of women. ;Secondary Objective: To measure side effects.;Primary end point(s): Changes in saccadic eye movement velocity compared to pre-treatment. Changes in subjective ratings of sedation and mood symptoms compared to pre-treatment.

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Countries

Sweden

Outcome results

None listed

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