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Trial History Detail on 2005-09-06

CUHK_CCT00004

2005-09-06

Retrospective

Department of Obstetrics and Gynaecology

Nil

Nil

Chan Shing Chee, Symphorosa

Tel

Tel 2632 2810

Chan Shing Chee, Symphorosa

Tel

Tel 2632 2810

Randomized Control Trial of Levo-norgestrel Intrauterine System in Women Receiving Tamoxifen for Carcinoma of Breast

Yes

2001-03-20

Carcinoma of Breast on Tamoxifen

Device

Levo-norgestrel Intrauterine System (LNG-IUS, that is mirena)

2 years and 6 months

Surveillance (with transvaginal ultrasound scan and outpatient hysteroscopy) for control group against Surveillance (TVS and outpatient hysteroscopy) and intervention with mirena insertion for the intervention group

Inclusion Criteria: 1. Patients with breast cancer using tamoxifen as an adjuvant therapy 2. Patients willing to give written consent to participate the study Exclusion Criteria: 1. Patients with previous history of endometrial hyperplasia or endometrial carcinoma 2. Patients who are contraindicated to the use of LNG-IUS 3. Patients who have no intact uterus 4. Patients refuse to participate the study

Randomized

Placebo

Open label

Parallel

2001-04-01

120

Complete

Endometrial pathology by hysteroscopy in both groups

Histology of endometrial pathology in both groups

No

2009-11-25


Yes

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