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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755963
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : July 22, 2011
Information provided by:
Medical University of Vienna

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
Hormone Replacement Drug: estradiol valerate Drug: micronized progesterone Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
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 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

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
Drug: placebo

Primary Outcome Measures :
  1. Serotonin-1A receptor binding potential [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00755963

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Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Siegfried Kasper, MD Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ao. Univ.-Prof. Dr. DDr.h.c. Siegfried Kasper, Department of Psychiatry and Psychotherapy, Medical University of Vienna Identifier: NCT00755963    
Other Study ID Numbers: PM-20070724
EudraCT: 2007-005685-12
EC 593/2007
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2010
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female