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
| ISRCTN | ISRCTN46431737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46431737 |
| Secondary identifying numbers | N0123109192 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 13/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J Konje
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| nicola.turner@uhl-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levonorgestrel, tamoxifen |
| Primary outcome measure | Data not yet available. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2002 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Data not yet available. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University Hospitals of Leicester NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2009 | Yes | No |
Editorial Notes
13/02/2018: Publication reference added.
