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Clinical Trials/EUCTR2007-005685-12-AT
EUCTR2007-005685-12-AT
Active, not recruiting
Not Applicable

The influence of hormone replacement therapy on the cerebral serotonin-1A receptor distribution and mood in postmenopausal women - Hormone replacement therapy and serotonin-1A receptors

niversitätsklinik für Psychiatrie und Psychotherapie, Klin. Abteilung f. Biologische Psychiatrie0 sitesJuly 7, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
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.
Sponsor
niversitätsklinik für Psychiatrie und Psychotherapie, Klin. Abteilung f. Biologische Psychiatrie
Status
Active, not recruiting
Last Updated
10 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 7, 2008
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
niversitätsklinik für Psychiatrie und Psychotherapie, Klin. Abteilung f. Biologische Psychiatrie

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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