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

NCT ID: NCT00755963

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-07-31

Brief Summary

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.

Conditions

Hormone Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

estradiol valerate

Intervention Type: DRUG

Progynova® 21; 2mg/d

micronized progesterone

Intervention Type: DRUG

Utrogestan®; 200mg/d

2

Group Type: EXPERIMENTAL

estradiol valerate

Intervention Type: DRUG

Progynova® 21; 2mg/d

3

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

maltodextrin

Interventions

estradiol valerate

Progynova® 21; 2mg/d

Intervention Type: DRUG

micronized progesterone

Utrogestan®; 200mg/d

Intervention Type: DRUG

placebo

maltodextrin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Principal Investigators

Siegfried Kasper, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

Locations

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

Vienna, Vienna, Austria

Countries

Austria

References

Kranz GS, Rami-Mark C, Kaufmann U, Baldinger P, Hahn A, Hoflich A, Savli M, Stein P, Wadsak W, Mitterhauser M, Winkler D, Lanzenberger R, Kasper S. Effects of hormone replacement therapy on cerebral serotonin-1A receptor binding in postmenopausal women examined with [carbonyl-(1)(1)C]WAY-100635. Psychoneuroendocrinology. 2014 Jul;45:1-10. doi: 10.1016/j.psyneuen.2014.03.004. Epub 2014 Mar 20.

Reference Type: DERIVED

PMID: 24845171 (View on PubMed)

Other Identifiers

EudraCT: 2007-005685-12

Identifier Type: -

Identifier Source: secondary_id

EC 593/2007

Identifier Type: -

Identifier Source: secondary_id

PM-20070724

Identifier Type: -

Identifier Source: org_study_id