Postmenopausal SymptomsPhase 4NCT01295892
Chronic Effects of Estrogen in Microcirculation
A Phase 4 study testing Estrogen in people with Postmenopausal Symptoms, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention. Read more about this study
- Who is it for?
- Ages 48 to 55 years, women only
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- Estrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Apr 2013
- 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 48 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- History of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of FSH > 35 IU/L
- BMI between 27 to 34.9 kg/m²
- Non-smokers
- Not on use of any hormones or supplements for a minimum of 6 months prior to the study
- No absolute contraindications to the use of physiological replacement doses of estrogen
Who cannot join
- Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
- Diabetes mellitus, glucose intolerance or altered fasting glucose
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular
Rio de Janeiro
About this study
Official title: Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women
This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.
Read the detailed description
Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. Traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. At this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. Our aims are to investigate estrogen´s chronic effects on microcirculation.
The study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. At baseline and after intervention, nailfold videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects.
- Conditions
- Postmenopausal Symptoms
- Being tested
- Estrogen
- Keywords
- menopause, obesity, capillary, microcirculation, estrogen, Microvascular Function
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
transdermal 17-β-estradiol 1mg/day during three months
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo (transdermal gel) Receives: Drug: Estrogen |
| Estrogen | Experimental | 1mg of 17B-estradiol/day (transdermal gel) Receives: Drug: Estrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)
Measured: 03 months
Secondary outcomes (1)
blood viscosity(the values are expressed in centipoises)
evaluate the change in blood viscosity after 3 months of treatment
Measured: 03 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionApr 2013
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 Postmenopausal SymptomsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer de Aguiar, Rio de Janeiro State University
- Investigators
- Diogo Panazzolo, Principal investigator, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295892
- Sponsor's protocol ID
- pkvw6k
- Status last verified
- Apr 2013
- First submitted
- 14 Feb 2011
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
da Silva LH, Panazzolo DG, Marques MF, Souza MG, Paredes BD, Nogueira Neto JF, Leao LM, Morandi V, Bouskela E, Kraemer-Aguiar LG. Low-dose estradiol and endothelial and inflammatory biomarkers in menopausal overweight/obese women. Climacteric. 2016 Aug;19(4):337-43. doi: 10.1080/13697137.2016.1180676. Epub 2016 May 12.
PubMed 27170466
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women
- ClinicalTrials.gov ID
- NCT01295892
- Acronym / sponsor ID
- pkvw6k
- Conditions
- Postmenopausal Symptoms
- Keywords
- menopause, obesity, capillary, microcirculation, estrogen, Microvascular Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Feb 2011 (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.
This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.
Detailed description
Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. Traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. At this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. Our aims are to investigate estrogen´s chronic effects on microcirculation.
The study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. At baseline and after intervention, nailfold videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Estrogenplacebo (transdermal gel) |
| Estrogen | Experimental | Drug: Estrogen1mg of 17B-estradiol/day (transdermal gel) |
Who may qualify
- Ages
- 48 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- History of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of FSH > 35 IU/L
- BMI between 27 to 34.9 kg/m²
- Non-smokers
- Not on use of any hormones or supplements for a minimum of 6 months prior to the study
- No absolute contraindications to the use of physiological replacement doses of estrogen
Key exclusion criteria (2 listed)
- Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
- Diabetes mellitus, glucose intolerance or altered fasting glucose
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 |
|---|---|---|
| Estrogentransdermal 17-β-estradiol 1mg/day during three months | Drug | Estrogen, placebo |
Primary outcome
functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)
Time frame: 03 months
1 secondary outcome
blood viscosity(the values are expressed in centipoises)
Time frame: 03 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 18 Apr 2013.
- Derived from this study: PubMed 27170466da Silva LH, Panazzolo DG, Marques MF, Souza MG, Paredes BD, Nogueira Neto JF, Leao LM, Morandi V, Bouskela E, Kraemer-Aguiar LG. Low-dose estradiol and endothelial and inflammatory biomarkers in menopausal overweight/obese women. Climacteric. 2016 Aug;19(4):337-43. doi: 10.1080/13697137.2016.1180676. Epub 2016 May 12.
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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.
Diogo Panazzolo principal investigator
Rio de Janeiro State University
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 Estrogen in people with Postmenopausal Symptoms, run by Rio de Janeiro State University at 1 site in Brazil.
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 5 inclusion and 2 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 18 Apr 2013. 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 Brazil. 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?
functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area) (time frame: 03 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 NCT01295892, 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 18 Apr 2013.