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Trial History Detail on 2015-09-15

CUHK_CCRB00476

2015-09-15

Prospective

nil

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

nil

nil

Not Applicable

LAW Tracy Sze Man

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

26322748

tracylaw@cuhk.edu.hk

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

HONG KONG

Tracy Sze Man LAW

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

26322748

tracylaw@cuhk.edu.hk

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

Hong Kong

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

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

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)

An RCT on medical management of uterine fibroid

HONG KONG

Yes

2015-02-17

Joint CUHK-NTEC Clinical Research Ethics Committee

CRE-2014.574

uterine fibroid

Drug

depot medroxyprogesterone acetate (DMPA)

Intramuscular injection

150mg

6 months

twice

GnRH analogue

Intramuscular injection

11.25mg

6 months

twice

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

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

18

50

Female

Interventional

Randomized

Double-blinded randomized controlled

Active

Double-blind

Parallel

4

2016-01-01

203

Not Yet Recruiting

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

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

PBAC score will be recorded at first, 3-month and 6-month visits.

Menstrual flow/pain based on visual analogue scale (VAS);

Usage of tranexamic acid/mefenamic acid/unintended clinical consultation or admission;

Changes, if any, of the fibroid/uterine size;

Symptom and quality of life assessment using UFS-QOL, SF-12, FSFI, PFDI, PFIQ questionnaires;

Adverse effects of treatment.

No

2016-04-05

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