Bilateral oophorectomy and hysterectomy and a wish for hormonal replacement therapy afterwards.
Conditions
Interventions
Trade Name: Undestor
Pharmaceutical Form:
INN or Proposed INN: testosterone undecanoate
Other descriptive name: undestor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Karolinska Institutet, Institutionen för klinisik neurovetenskap, sektion för psykiatri
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: current and past major psychiatric disorder, somatic disorder or current medication which are likely to interfere with the serotonergic system. Nonlocalized tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Sweden
Outcome results
None listed