Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00476

2 Trial Registration Date

2015-09-15

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

Department of Obstetrics & Gynaecology, the Chinese University of Hong Kong

5 Primary Sponsor

nil

6 Secondary Sponsor

nil

Function

Not Applicable

Please specify

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

i Name

LAW Tracy Sze Man

ii Address

Department of Obstetrics & Gynaecology, the Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., HONG KONG

iii Phone

26322748

iv Email

tracylaw@cuhk.edu.hk

v Affiliation

Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong

vi Country

HONG KONG

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

i Name

Tracy Sze Man LAW

ii Address

Department of Obstetrics & Gynaecology, the Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., HONG KONG

iii Phone

26322748

iv Email

tracylaw@cuhk.edu.hk

v Affiliation

Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

A double-blinded, randomized controlled trial on depot medroxyprogesterone acetate (DMPA) and GnRH analogue in pre-menopausal women suffered from uterine fibroid

10 Public Title

A double-blinded, randomized controlled trial on depot medroxyprogesterone acetate (DMPA) and GnRH analogue in pre-menopausal women suffered from uterine fibroid

i Public Title in Chinese 研究名稱

甲羥孕酮 (DMPA) 及促性腺激素釋放激素 (GnRHa) 於患子宮肌瘤的絕經前婦女之治療效果之研究 (隨機雙盲對照試驗)

11 Short Title (Optional)

An RCT on medical management of uterine fibroid

12 Countries of Recruitment

HONG KONG

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-02-17

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2014.574

14 Medical Condition Being Studied

uterine fibroid

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

depot medroxyprogesterone acetate (DMPA)

iii Dosage form of the intervention

Intramuscular injection

iv Dosage of the intervention

150mg

v Duration of the intervention

6 months

vi Frequency of the intervention

twice

16 Comparative Treatments

i Description/ name of comparative treatments

GnRH analogue

ii Dosage form of the comparative treatments

Intramuscular injection

iii Dosage of the comparative treatments

11.25mg

iv Duration of the comparative treatments

6 months

v Frequency of the comparative treatments

twice

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. 18-50 years old

2. Women with at least one fibroid ≥ 3cm

3. Pictorial blood loss assessment chart (PBAC) score more than 100 (~80ml) for 2 months

4. Uterine size more than or equal to 12 weeks

5. Uterine size less than 12 weeks

6. Refuse or fail LNG-IUS or endometrial ablation

ii Exclusion Criteria

1. Menopausal women

2. Women planning for pregnancy

3. Women with gynaecological premalignant or malignant uterine pathologies

4. Women with type 1 submucosal uterine fibroid

5. Contraindication to the use of DMPA or GnRHa

6. Women with concomitant endometrioma >5cm and/or adenomyosis/adenomyoma

7. Concomitant use of Chinese herbal medicine/ hormonal replacement therapy/tamoxifen

8. Coagulation problem or using medication which affect clotting function

9. Use of DMPA/GnRHa in past 6 months

10. Uncontrolled thyroid dysfunction

iii Age Minimum

18

iv Age Maximum

50

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Double-blinded randomized controlled

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-01-01

21 Target Sample Size

203

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Efficacy of treatment for women with heavy menstrual bleeding and fibroids based on their menstrual flow.

ii The metric or method of measurement used

Menstrual flow is monitored by using PBAC as assessment. PBAC score of 75 or lower per menstrual cycle is regarded as successful treatment outcome.