Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes