Vascular Effect of Estradiol Valerate Versus Placebo Eval... | NCT02161614

Studies
Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

NCT02161614

Sponsor

Federal University of Minas Gerais

Status

Completed

Last Update Posted

Jan 15, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Flow-mediated Dilation Evaluation of the Brachial Artery

Interventions

Estradiol valerate
Placebo

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jun 10, 2014

First Submission Date that Met QC Criteria

Jun 10, 2014

First Posted Date

Jun 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2016

Last Update Posted Date

Jan 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Selmo Geber, Professor, Federal University of Minas GeraisPrincipal Investigator

Lead Sponsor

Federal University of Minas GeraisOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do estado de Minas Gerais	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the vascular effects of estradiol valerate 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 estradiol valerate on flow-mediated dilation of the brachial artery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Patients will use placebo for 30 days	Drug: Placebo
Estradiol Valerate	Experimental	patients will use estradiol valerate 1mg/day during 30 days	Drug: Estradiol valerate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Estradiol valerate	Drug		Estradiol Valerate
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Flow-mediated dilation of the brachial artery		30 days after treatment started

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH)>30International Units / Liter
Healthy women
Women that were not using drugs with potential vascular effect within the last 1 year
Women that never used hormone replacement therapy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Selmo Geber, MD PhD	Federal University of Minas Gerais	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Clinicas - Universidade Federal de Minas Gerais		Belo Horizonte	Minas Gerais	30130100	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21471823	Background	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.

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds