NCT01543399

Brief Summary

The interruption of the secretion of sex steroids occurring during menopause, causes a change in vascular pattern at various levels. As a result, several agencies have side effects that interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. In previous studies the investigators showed the effect of sex steroids in premenopausal women in the conjugated equine estrogens, medroxyprogesterone acetate and tibolone in menopausal women, on the central retinal arteries. The aim of this study is to evaluate the effects of Tibolone in Flow-Mediated Dilatation of the brachial artery.

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 Mar 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

First Submitted

Initial submission to the registry

February 21, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
2.9 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

2.9 years

First QC Date

February 21, 2012

Last Update Submit

April 2, 2015

Conditions

Menopause

Keywords

TiboloneclimactericDopplerhormone replacement therapy

Outcome Measures

Primary Outcomes (1)

  • Diameter measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of tibolone.

    We will evaluate the vascular effect of Tibolone on the brachial artery. The diameter of the artery will be measured before and one month after use of Tibolone and, in both situations, before and after the use of a cuff in the forearm. Measurement will be in millimeters.

    30 days

Secondary Outcomes (1)

  • Patients symptoms before and after the use of Tibolone

    30 days

Study Arms (2)

Tibolone use

EXPERIMENTAL

climacteric women will use Tibolone for 30 days

Drug: Tibolone

Placebo use

PLACEBO COMPARATOR

climacteric women will use placebo for 30 days

Drug: Placebo

Interventions

TiboloneDRUG

Experimental group will use 2.5mg of tibolone for 30 days

Also known as: Livial
Tibolone use
PlaceboDRUG

patients of the placebo group will use placebo one a day for 30 days

Placebo use

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Related Publications (1)

  • de Souza MA, de Souza BM, Geber S. Vascular resistance of central retinal and ophthalmic arteries in postmenopausal women after use of tibolone. Menopause. 2012 Mar;19(3):328-31. doi: 10.1097/gme.0b013e3182290b26.

    PMID: 22042323BACKGROUND

MeSH Terms

Interventions

tibolone

Study Officials

  • Selmo Geber, MD PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

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
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 5, 2012

Study Start

March 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)