Contact information
Type
Scientific
Primary contact
Dr J Konje
ORCID ID
Contact details
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 (0)116 258 4109
nicola.turner@uhl-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0123109192
Study information
Scientific title
The application of the levonorgestrel containing intrauterine contraceptive device in the prevention of endometrial changes induced by tamoxifen in women undergoing adjuvant therapy for breast cancer
Acronym
Study hypothesis
To find out whether giving this treatment at the time of initiation of tamoxifen treatment will prevent the changes induced by this drug from developing in the first instance.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Randomised controlled trial: prior to tamoxifen treatment, patient will receive either:
1. Levonorgestrel-containing intrauterine contraceptive device
2. Placebo
Intervention type
Drug
Phase
Not Applicable
Drug names
Levonorgestrel, tamoxifen
Primary outcome measure
Data not yet available.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Data not yet available.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospitals of Leicester NHS Trust (UK)
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
Basic results (scientific)
Publication list
2009 results in https://www.ncbi.nlm.nih.gov/pubmed/19576623