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Completed

NCT Number: NCT00755963

Effects of Hormone Replacement Therapy on the Serotonergic System 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.

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Key information

Conditions

Hormone Replacement

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

estradiol valerate

Drug

Progynova® 21; 2mg/d

Micronized progesterone

Drug

Utrogestan®; 200mg/d

Placebo

Drug

maltodextrin

Primary outcomes

  1. Serotonin-1A receptor binding potential

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 19, 2008
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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