Hormonersättningseffekt på serotoninåterupptag hos ooforektomerade kvinnor

Phase 1

• Conditions: Bilateral oophorectomy and hysterectomy and a wish for hormonal replacement therapy afterwards.

• Registration Number: EUCTR2004-002677-24-SE
• Lead Sponsor: Karolinska Institutet, Institutionen för klinisik neurovetenskap, sektion för psykiatri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-24
• Study Completion: 2011-12-22
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Women eligible for inclusion are women who are about to be oophorectomized bilateraly or have recently been and who are 40-60 years old and wants hormone replacement treatment, and can give 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

current and past major psychiatric disorder, somatic disorder or current medication which are likely to interfere with the serotonergic system. Nonlocalized tumor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study effect of serotonergic reuptake by PET imaging using the radioligand [11C]MADAM modulated by oestrogen replacement alone and in combination with testosterone in women who have recently been oophorectomized and hysterectomized for benign disease or localized tumor;Secondary Objective: Study effects on wellbeing, personality and neuropsychology in relation to PET-data as a consequence of hormonal replacement therapy in the form of estrogen alone and in combination with testosterone.;Primary end point(s): Measurement of serotonergic reuptake transporter by positronic emission tomography using [c11]MADAM as radioligand at baseline, repeated after hormonal replacement therapy with IMP2 2-3 months and then with addition of IMP1 for 2-3 months.