Unspecified Injury of Brachial Artery, Left Side, Initial EncounterEDILANCT01482416
Vascular Effect of Estrogens Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
A study testing Estrogens, Conjugated (USP) in people with Unspecified Injury of Brachial Artery, Left Side, Initial Encounter, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the vascular effects of estrogens on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unspecified Injury of Brachial Artery, Left Side, Initial Encounter
- What is being tested?
- Estrogens, Conjugated (USP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Aug 2014
- Phase
- Interventional
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women without menstrual cycles within the last 12 months and FSH > 30IU/L
- Healthy women
- Women that were not using drugs with potential vascular effect within the last 1 year
- Women that never used hormone replacement therapy
Who cannot join
- Smoking
- Blood Pressure > 160/90 mm Hg.
- Breast and or endometrial cancer
- History of acute myocardial infarction
- Diabetes
- Vaginal bleeding of any origin
- Hepatic disease
- Thrombophlebitis or thromboembolic disorders
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130100
About this study
Official title: Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
The aim of this study is to evaluate the vascular effects of estrogens on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.
Read the detailed description
The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of conjugated equine estrogen on flow-mediated dilation of the brachial artery.
- Being tested
- Estrogens, Conjugated (USP), Placebo
- Keywords
- hormone replacement therapy, Doppler velocimetry, Flow-mediated dilation, menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrogens, Conjugated (USP)Drug
Also called Premarin
Experimental group will use 0.625mg/day during 30 days
PlaceboDrug
Placebo group will use placebo once/day during 30 days
| Study group | Role | What they receive |
|---|---|---|
| Estrogen use | Experimental | climacteric women will use conjugated equine estrogens Receives: Drug: Estrogens, Conjugated (USP) |
| use of Placebo | Placebo comparator | climacteric women will use placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation of the brachial artery
Flow-mediated dilation will be measured by high resolution ultrasound
Measured: one month after treatment started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unspecified Injury of Brachial Artery, Left Side, Initial EncounterStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selmo Geber, Federal University of Minas Gerais
- Investigators
- Selmo Geber, MD PhD, Principal investigator, Medical School of Universidade Federal de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482416
- Sponsor's protocol ID
- E.FR - 245365
- Acronym
- EDILA
- Status last verified
- Aug 2014
- First submitted
- 27 Nov 2011
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Faria AF, de Souza MA, Geber S. Vascular resistance of central retinal artery is reduced in postmenopausal women after use of estrogen. Menopause. 2011 Aug;18(8):869-72. doi: 10.1097/gme.0b013e31820cc60c.
PubMed 21471823Hurtado R, Celani M, Geber S. Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial. Climacteric. 2016 Oct;19(5):448-51. doi: 10.1080/13697137.2016.1201809. Epub 2016 Jul 16.
PubMed 27427235
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT01482416
- Acronym / sponsor ID
- EDILA / E.FR - 245365
- Keywords
- hormone replacement therapy, Doppler velocimetry, Flow-mediated dilation, menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Nov 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.
The aim of this study is to evaluate the vascular effects of estrogens on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.
Detailed description
The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of conjugated equine estrogen on flow-mediated dilation of the brachial artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogen use | Experimental | Drug: Estrogens, Conjugated (USP)climacteric women will use conjugated equine estrogens |
| use of Placebo | Placebo comparator | Drug: Placeboclimacteric women will use placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women without menstrual cycles within the last 12 months and FSH > 30IU/L
- Healthy women
- Women that were not using drugs with potential vascular effect within the last 1 year
- Women that never used hormone replacement therapy
Key exclusion criteria (8 listed)
- Smoking
- Blood Pressure > 160/90 mm Hg.
- Breast and or endometrial cancer
- History of acute myocardial infarction
- Diabetes
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 |
|---|---|---|
| Estrogens, Conjugated (USP)Also: PremarinExperimental group will use 0.625mg/day during 30 days | Drug | Estrogen use |
| PlaceboPlacebo group will use placebo once/day during 30 days | Drug | use of Placebo |
Primary outcome
Flow-mediated dilation of the brachial artery
Time frame: one month after treatment started
Flow-mediated dilation will be measured by high resolution ultrasound
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 15 Aug 2014.
- Background: PubMed 21471823Faria AF, de Souza MA, Geber S. Vascular resistance of central retinal artery is reduced in postmenopausal women after use of estrogen. Menopause. 2011 Aug;18(8):869-72. doi: 10.1097/gme.0b013e31820cc60c.
- Derived from this study: PubMed 27427235Hurtado R, Celani M, Geber S. Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial. Climacteric. 2016 Oct;19(5):448-51. doi: 10.1080/13697137.2016.1201809. Epub 2016 Jul 16.
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.
Selmo Geber, MD PhD principal investigator
Medical School of Universidade Federal de Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estrogens, Conjugated (USP) in people with Unspecified Injury of Brachial Artery, Left Side, Initial Encounter, run by Federal University of Minas Gerais 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 4 inclusion and 8 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 15 Aug 2014. 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.
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?
Flow-mediated dilation of the brachial artery (time frame: one month after treatment started). 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 NCT01482416, which also lists 2 linked publications.
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 15 Aug 2014.