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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00755963 |
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 | Intervention | Phase |
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Hormone Replacement Therapy |
Drug: estradiol valerate Drug: micronized progesterone Other: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
Official Title: | The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: estradiol valerate
Progynova® 21 mite; 2mg/d
Drug: micronized progesterone
Utrogestan®; 200mg/d
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2: Experimental |
Drug: estradiol valerate
Progynova® 21 mite; 2mg/d
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3: Placebo Comparator
Placebo
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Other: placebo
placebo
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Ages Eligible for Study: | 50 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion criteria
Contact: Siegfried Kasper, MD | 00431404003568 | sci-biolpsy@meduniwien.ac.at |
Contact: Rupert Lanzenberger, MD | 00431404003825 | rupert.lanzenberger@meduniwien.ac.at |
Austria | |
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy | |
Vienna, Austria, 1090 |
Principal Investigator: | Siegfried Kasper, MD | Medical University of Vienna, Dept. of Psychiatry and Psychotherapy |
Responsible Party: | Department of Psychiatry and Psychotherapy, Medical University of Vienna ( ao. Univ.-Prof. Dr. DDr.h.c. Siegfried Kasper ) |
Study ID Numbers: | PM-20070724, EudraCT: 2007-005685-12, EC 593/2007 |
Study First Received: | September 18, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00755963 |
Health Authority: | Austria: Ethikkommission |
Progesterone Benzoates Estradiol 3-benzoate Estradiol valerate |
Estradiol 17 beta-cypionate Polyestradiol phosphate Serotonin Estradiol |
Estrogens Contraceptive Agents Progestins Therapeutic Uses Physiological Effects of Drugs |
Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |