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FARMAKOKINETISKA EGENSKAPER HOS ISOALLOPREGNANOLON OCH ANTAGONISM AV ALLOPREGNANOLONS SEDERINGS EFFEKT HOS KVINNOR. Pharmacokinetic properties of isoallopregnanolone and antagonism of allopregnanolones sedative effect in women - isoallo

FARMAKOKINETISKA EGENSKAPER HOS ISOALLOPREGNANOLON OCH ANTAGONISM AV ALLOPREGNANOLONS SEDERINGS EFFEKT HOS KVINNOR. Pharmacokinetic properties of isoallopregnanolone and antagonism of allopregnanolones sedative effect in women - isoallo

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000944-98-SE
Enrollment
Unknown
Registered
2005-03-11
Start date
2005-05-02
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Premenstrual Dysphoric Disorder (PMDD) / Severe Premenstrual Syndrome (PMS)

Interventions

Product Name: Isoallopregnanolone Product Code: UC1010 Pharmaceutical Form: Solution for injection CAS Number: 516-55-2 Current Sponsor code: UC1010 Other descriptive name: Isoallopregnanolone Concent

Sponsors

Norlands University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy women aged 18-40 regularly menstruation (28±3days) and with a weight under 80 kg. 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. Any form of hormone therapy including contraceptives last six months. 2. Treatment with benzodiazepines of other psychotropic drugs during the last three months. 3. Ongoing or earlier psychiatric disorder. 4. Ongoing or earlier somatic disorder in the liver, kidney, hart, lungs, neurological or gynaecologic disorders. 5. Serum positive infection for Hepatitis B or risk for positive HIV infection. 6. Usage of ilegal drug. 7. Usage of more than 72g alcohol during one day last four weeks before the study. 8. Abuse of alcohol or drugs. 9. Changed diurnal rhythm 10. Significant change in day time 11. Planning pregnancy. 12. Blood pressure 100 / 170 mmHg 13. Clinical significant changes in examinations and routine laboratory samples 14. Positive pregnancy test

Design outcomes

Primary

MeasureTime frame
Main Objective: To measure pharmacokinetic parameters of isoallopergnanolone ;Secondary Objective: To investigate if isoallopregnanolone influences sedation and maximal saccadic velocity. To investigate if isoallopregnanolone inhibits allopregnanolone’s sedative effect. ;Primary end point(s): Primary end points are: 1) Serum concentrations of isoallopregnanolone and allopregnanolone. 2) Maximal velocity of the saccade measured with electrooculography—

Countries

Sweden

Outcome results

None listed

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