Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00004

2 Trial Registration Date

2005-09-06

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Department of Obstetrics and Gynaecology

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Chan Shing Chee, Symphorosa

ii Address

iii Phone

Tel

iv Email

Tel 2632 2810

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Chan Shing Chee, Symphorosa

ii Address

iii Phone

Tel

iv Email

Tel 2632 2810

v Affiliation

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2001-03-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Carcinoma of Breast on Tamoxifen

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

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

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 years and 6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2001-04-01

21 Target Sample Size

120

22 Recruitment Status

Complete

23 Primary Outcome

Endometrial pathology by hysteroscopy in both groups

24 Secondary Outcome

Histology of endometrial pathology in both groups

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-25

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-09-06