Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women - Full Text View

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00755963

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Hormone Replacement Therapy

Drug Information available for: Estradiol Estradiol 3-benzoate Progesterone Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Serotonin-1A receptor binding potential [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: estradiol valerate Progynova® 21; 2mg/d Drug: micronized progesterone Utrogestan®; 200mg/d
2: Experimental	Drug: estradiol valerate Progynova® 21; 2mg/d
3: Placebo Comparator Placebo	Other: placebo maltodextrin

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755963

Contacts

Contact: Siegfried Kasper, MD	00431404003568	sci-biolpsy@meduniwien.ac.at
Contact: Rupert Lanzenberger, MD	00431404003825	rupert.lanzenberger@meduniwien.ac.at

Locations

Austria
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy	Recruiting
Vienna, Austria, 1090
Principal Investigator: Siegfried Kasper, MD

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Siegfried Kasper, MD

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

More Information

No publications provided

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:	June 15, 2009
ClinicalTrials.gov Identifier:	NCT00755963 History of Changes
Health Authority:	Austria: Ethikkommission

Additional relevant MeSH terms:

Estrogens
Progesterone
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate

Reproductive Control Agents
Hormones
Estradiol
Pharmacologic Actions
Progestins
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 25, 2009