Status:
TERMINATED
Ulipristal Acetate in Symptomatic Uterine Fibroid
Lead Sponsor:
Mỹ Đức Hospital
Conditions:
Uterine Fibroid
Heavy Menstrual Bleeding
Eligibility:
FEMALE
18-48 years
Phase:
PHASE4
Brief Summary
This study evaluates the effectiveness and safety of ulipristal acetae (UPA) in women with symptomatic uterine fibroids. Those who fulfilled inclusion/exclusion criteria will be treated UPA at daily d...
Detailed Description
There is increasing evidence approving role of medical therapy in treatment of symptomatic uterine fibroid, in the context of women's desire to preserve fertility or not to undergo operation. Among t...
Eligibility Criteria
Inclusion
- Women aged 18-48
- Regular cycle of 22-35 days interval and FSH \<=20 mUI/mL.
- \>=1 uterine fibroid of 3\<= d \< 10cm (regardless of location), diagnosed by transvaginal ultrasound.
- Heavy menstrual bleeding (blood loss \>80ml/cycle).
- Uterine size \< 16 weeks of GA on clinical examination.
- Agree to participate in the study.
Exclusion
- Previous or current treatment of uterus, cervix, ovarian or breast cancer.
- Previous endometrial ablation or uterine artery embolization.
- Abnormal PAP's smear result within 12 months prior to recruitment.
- Endometrial hyperplasia within 6 months prior to recruitment.
- Uterine polyp \>2cm.
- Ovarian cysts 4cm diagnosed by transvaginal ultrasound.
- Severe anemia (Hb 6 g/dl) or indication for blood transfusion.
- Coagulation disorder indicated for treatment.
- Increased liver enzyme level of twofold or more than normal upper limit.
- Previous use of SPRM.
- Treatment of systemic progestin or intrauterine device or hormonal contraception within 2 months, or use of GnRH analogue within 5 months prior to recruitment.
- Current use of acetylsalicylic acid, mefenamic acid, anticoagulation agents, antifibrinolysis agents, or systemic corticoid
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04132349
Start Date
October 23 2019
End Date
April 1 2020
Last Update
April 13 2020
Active Locations (1)
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1
My Duc Hospital
Ho Chi Minh City, Vietnam