Healthy postmenopausal women receiving standard hormone replacement therapy are measured using positron emission tomography to investigate the effects of hormones on the cerebral serotonin-1A receptor.
Conditions
Interventions
Trade Name: UTROGESTAN
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: PROGYNOVA MITE
Pharmaceutical Form:
Sponsors
Universitätsklinik für Psychiatrie und Psychotherapie, Klin. Abteilung f. Biologische Psychiatrie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Postmenopausal females in good condition (over 14 months of amenorrhoea) • Age 50 - 65 years • Uni- or Multipara • Signed informed consent form • Consent not to participate in PET or SPECT studies with an added equivalence dose of over 15 mSv within 10 years following the final assessment of the participant in this study. 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: • Steroid hormone treatment within 6 months prior to the inclusion • Current substance abuse • History of any malign illness • Any implant or stainless steel graft • Concomitant neurological illness • Concomitant psychiatric disorder except anxiety disorders or depression • Treatment with a psychotropic agent targeting serotonin-1A and serotonin-2A receptors or the serotonin transporter such as buspirone, pindolol or SSRIs. • Clinically relevant abnormalities in the general physical examination and the routine laboratory screening • Concomitant major illness, especially: liver disease, disorder of the endocrine system, osteoporosis (when treated with vitamine D), any clinically relevant vascular or heart diseases • One of the following gynaecological diseases: ovariectomy, hysterectomy, endometriosis, myomatosis, cervical smear test: PAP > II • Extensive obesity (limiting factor is the bore of the MRI scanner) • Failures to comply with the study protocol or to follow the instructions of the investigating team. • Investigations using PET or SPECT within 10 years prior to the inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study investigates the influence of the steroid hormones estrogen and progesterone on the serotonin-1A receptor distribution in the human brain. The serotonin-1A receptor binding potential will be measured using positron emission tomography (PET) before and after 8 weeks of a daily hormone replacement therapy (HRT) in 30 medication-free postmenopausal women, which will be assigned to one of three treatment groups: one group (10 subjects) will be treated using a combination of oral estrogen (Progynova mite (R)) and micronized progesterone (Utrogestan(R)), the second group (10 subjects) receives an oral estrogen (Progynova mite (R)) and placebo, and the third group two placebos (matched to estrogen and progesterone administration).;Secondary Objective: A secondary objective of the trial is the assessment of effects of hormone replacement therapy on mood (depression and anxiety scores).;Primary end point(s): study ends with the second PET measurement after 8 weeks of hormone replacement therapy with either progesterone and estradiol / estradiol and placebo / or placebo. | — |
Countries
Austria
Outcome results
None listed