NCT01679795

Brief Summary

The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

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

Study Start

First participant enrolled

February 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

September 3, 2012

Last Update Submit

April 2, 2015

Conditions

Flow-mediated Dilation Evaluation of the Brachial Artery

Keywords

hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery

    Flow-mediated dilation will be measured by high resolution ultrasound

    30 days

Study Arms (2)

Tibolone

EXPERIMENTAL

patientes will use tibolone 2,5mg/day during 30 days

Drug: Tibolone

Placebo use

PLACEBO COMPARATOR

Patients will use placebo for 30 days

Drug: Placebo

Interventions

TiboloneDRUG
Also known as: Livial
Tibolone
PlaceboDRUG
Placebo use

Eligibility Criteria

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

You may qualify if:

  • Women without menstrual cycles whithin the last 12 months and FSH\>30IU/L
  • Healthy women
  • Women that were not using drugs with potential vascular effect whithin the last 1 year
  • Women that never used hormone replacement therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

MeSH Terms

Interventions

tibolone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 6, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

BR(1)