Hormone ReplacementPhase 4NCT00755963
Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women
A Phase 4 study testing estradiol valerate and micronized progesterone in people with Hormone Replacement, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hormone Replacement
- What is being tested?
- estradiol valerate and micronized progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- May 2009to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
Vienna, State of Vienna, 1090
About this study
Official title: The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution 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.
- Conditions
- Hormone Replacement
- Being tested
- estradiol valerate, micronized progesterone, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol valerateDrug
Progynova® 21; 2mg/d
micronized progesteroneDrug
Utrogestan®; 200mg/d
placeboDrug
maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: estradiol valerate; Drug: micronized progesterone |
| 2 | Experimental | Not described Receives: Drug: estradiol valerate |
| 3 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotonin-1A receptor binding potential
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startMay 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormone ReplacementStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Siegfried Kasper, MD, Principal investigator, Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755963
- Sponsor's protocol ID
- PM-20070724
- Other IDs
- EudraCT: 2007-005685-12, EC 593/2007
- Status last verified
- Jul 2010
- First submitted
- 18 Sep 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24845171
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00755963
- Acronym / sponsor ID
- PM-20070724
- Conditions
- Hormone Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: estradiol valerate, Drug: micronized progesterone |
| 2 | Experimental | Drug: estradiol valerate |
| 3 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estradiol valerateProgynova® 21; 2mg/d | Drug | 1, 2 |
| micronized progesteroneUtrogestan®; 200mg/d | Drug | 1 |
| placebomaltodextrin | Drug | 3 |
Primary outcome
Serotonin-1A receptor binding potential
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Derived from this study: PubMed 24845171Kranz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siegfried Kasper, MD principal investigator
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing estradiol valerate and micronized progesterone in people with Hormone Replacement, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serotonin-1A receptor binding potential (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00755963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.