uterine fibroid
Conditions
Interventions
Two s:GnRH analogue 11.25mg Intramuscular injection 6 months twice
Sponsors
Nil
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. 8-50 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.
Exclusion criteria
Exclusion criteria: 1. Menopaul women;2. Women planning for pregnancy; 3. Women with gynaecological premalignant or malignant uterine pathologies; 4. Women with type 1 submucol 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of treatment for women with heavy menstrual bleeding 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 6-month visits.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstrual flow/pain based on visual analogue scale (VAS);;Uge of tranexamic acid/mefenamic acid/unintended clinical consultation or admission;Changes, if any, of the fibroid/uterine size;Symptom quality of life assessment using UFS-QOL, SF-12, FSFI, PFDI, PFIQ questionnaires;Adverse effects of treatment; | — |
Countries
China
Contacts
Public ContactLAW Tracy Sze Man
Outcome results
None listed