Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL2-05682-099
Study information
Scientific title
Effects of micronised purified flavonoic fraction on microcirculation in women suffering from chronic venous disease
Acronym
Study hypothesis
Clinical efficacy of micronised purified flavonoic fraction over four menstrual cycles.
Ethics approval(s)
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
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Daflon®
Primary outcome measure
Effects on microcirculatory and biological parameters over four menstrual cycles
Secondary outcome measures
Safety
Overall study start date
22/07/2009
Overall study end date
30/04/2012
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
Study 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
ROR
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
Publication plan:
Summary results are published in https://clinicaltrials.servier.com.
Intention to publish date
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |