NCT00755963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2010

Enrollment Period

2.2 years

First QC Date

September 18, 2008

Last Update Submit

July 20, 2011

Conditions

Hormone Replacement

Outcome Measures

Primary Outcomes (1)

  • Serotonin-1A receptor binding potential

    24 months

Study Arms (3)

1

EXPERIMENTAL
Drug: estradiol valerateDrug: micronized progesterone

2

EXPERIMENTAL
Drug: estradiol valerate

3

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

estradiol valerateDRUG

Progynova® 21; 2mg/d

12
micronized progesteroneDRUG

Utrogestan®; 200mg/d

1
placeboDRUG

maltodextrin

3

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 24845171DERIVED

MeSH Terms

Interventions

EstradiolProgesterone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnenedionesPregnenesPregnanesCorpus Luteum HormonesProgesterone Congeners

Study Officials

  • Siegfried Kasper, MD

    Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 19, 2008

Study Start

May 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 22, 2011

Record last verified: 2010-07

Locations

AU(1)