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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ]

Enrollment: 30
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
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
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ao. Univ.-Prof. Dr. DDr.h.c. Siegfried Kasper, Department of Psychiatry and Psychotherapy, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00755963     History of Changes
Other Study ID Numbers: PM-20070724, EudraCT: 2007-005685-12, EC 593/2007
Study First Received: September 18, 2008
Last Updated: July 20, 2011
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Progesterone
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Estrogens
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 16, 2014