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

Medical University of Vienna

Status and phase

Completed

Phase 4

Conditions

Hormone Replacement

Treatments

Drug: estradiol valerate

Drug: placebo

Drug: micronized progesterone

Study type

Interventional

Funder types

Other

Identifiers

NCT00755963

PM-20070724

EC 593/2007

EudraCT: 2007-005685-12

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

50 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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