Condition category
Circulatory System
Date applied
20/07/2009
Date assigned
19/08/2009
Last edited
08/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eliete Bouskela

ORCID ID

Contact details

Instituto de Biologia Roberto Alcantara Gomes
Dept Ciências Fisiologicasências Fisiologicas
Rua Sao Francisco Xavier
524 - PHLC - Sala 104 - Lab. Presq em Microcirculaçao
Rio de Janeiro
20550-013
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL2-05682-099

Study information

Scientific title

Acronym

Study hypothesis

Clinical efficacy of micronised purified flavonoic fraction over four menstrual cycles.

Please note that as of 03/12/10, the anticipated end date has been extended from 30/06/10 to 30/04/12.

Please note that as of 29/11/2012, the target number of participants was updated from 180 to 240.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Single-centre double-blind randomised placebo-controlled parallel-group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic venous disease

Intervention

Micronised purified flavonoic fraction 500 mg over four menstrual cycles versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Daflon®

Primary outcome measures

Effects on microcirculatory and biological parameters over four menstrual cycles

Secondary outcome measures

Safety

Overall trial start date

22/07/2009

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 29/11/2012:
1. Female suffering from primary chronic venous disease
2. Aged 18 to 30 years old

Previous inclusion criteria until 29/11/2012:
1. Female suffering from primary chronic venous disease
2. Aged 18 to 50 years old

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

240

Participant exclusion criteria

1. Patients with irregular menstrual cycles
2. Women of childbearing potential without effective contraception

Recruitment start date

22/07/2009

Recruitment end date

30/04/2012

Locations

Countries of recruitment

Brazil

Trial participating centre

Instituto de Biologia Roberto Alcantara Gomes
Rio de Janeiro
20550-013
Brazil

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes