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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00755963
First received: September 18, 2008
Last updated: July 20, 2011
Last verified: July 2010

September 18, 2008
July 20, 2011
May 2009
July 2011   (final data collection date for primary outcome measure)
Serotonin-1A receptor binding potential [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00755963 on ClinicalTrials.gov Archive Site
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Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women
The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Hormone Replacement
  • Drug: estradiol valerate
    Progynova® 21; 2mg/d
  • Drug: micronized progesterone
    Utrogestan®; 200mg/d
  • Drug: placebo
    maltodextrin
  • Experimental: 1
    Interventions:
    • Drug: estradiol valerate
    • Drug: micronized progesterone
  • Experimental: 2
    Intervention: Drug: estradiol valerate
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: placebo
Kranz GS, Rami-Mark C, Kaufmann U, Baldinger P, Hahn A, Höflich A, Savli M, Stein P, Wadsak W, Mitterhauser M, Winkler D, Lanzenberger R, Kasper S. Effects of hormone replacement therapy on cerebral serotonin-1A receptor binding in postmenopausal women examined with [carbonyl-¹¹C]WAY-100635. Psychoneuroendocrinology. 2014 Jul;45:1-10. doi: 10.1016/j.psyneuen.2014.03.004. Epub 2014 Mar 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Female
50 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00755963
PM-20070724, EudraCT: 2007-005685-12, EC 593/2007
Yes
ao. Univ.-Prof. Dr. DDr.h.c. Siegfried Kasper, Department of Psychiatry and Psychotherapy, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Siegfried Kasper, MD Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
Medical University of Vienna
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP