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Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00755963
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
26
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Menopausal and postmenopausal women compose almost 20% of the Austrian population. Two thirds of all austrian women suffering from depression or anxiety disorders are over 45 years old. The serotonergic system, partially regulated by the steroid hormones estrogen and progesterone, plays a major role in the pathogenesis and treatment of these illnesses. To examine the effect of the hormone replacement therapy on the serotonergic system, twenty-four postmenopausal women will be measured using positron emission tomography (PET). The volunteers will participate in two PET scans. The first PET scan will be performed right before the hormone treatment starts, the second PET scan about 8 weeks after daily treatment with (1) a combination of estrogen and progesterone or (2) estrogen and placebo. This imaging study hypothesizes that the expression of the main inhibiting serotonergic receptor (the serotonin-1A receptor) will be altered by the hormone therapy. The results of the study might lead to new strategies in the treatment of psychiatric illnesses during and after the menopausal transition.

Condition or Disease Intervention/Treatment Phase
  • Drug: estradiol valerate
  • Drug: micronized progesterone
  • Drug: placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: estradiol valerate
Progynova® 21; 2mg/d

Drug: micronized progesterone
Utrogestan®; 200mg/d
Experimental: 2

Drug: estradiol valerate
Progynova® 21; 2mg/d
Placebo Comparator: 3

Placebo

Drug: placebo
maltodextrin

Outcome Measures

Primary Outcome Measures

  1. Serotonin-1A receptor binding potential [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

Inclusion Criteria

  • Postmenopausal females (over 14 months of amenorrhoea)

  • Age 50 - 65 years

  • 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

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, disorders 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, cervical smear test: PAP > II

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna, Dept. of Psychiatry and Psychotherapy Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Siegfried Kasper, MD, Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00755963
Other Study ID Numbers:
  • PM-20070724
  • EudraCT: 2007-005685-12
  • EC 593/2007
First Posted:
Sep 19, 2008
Last Update Posted:
Jul 22, 2011
Last Verified:
Jul 1, 2010
Additional relevant MeSH terms:
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol
Polyestradiol phosphate
Progesterone

Study Results

No Results Posted as of Jul 22, 2011