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 |
| Protocol serial number | N0123109192 |
| Sponsor | Department of Health (UK) |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levonorgestrel, tamoxifen |
| Primary outcome measure(s) |
Data not yet available. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/02/2018: Publication reference added.
