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 dose of 5mg.
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 these hormonal therapies, ulipristal acetate (UPA) is an orally administered selective progesterone receptor modulator commonly prescribed for treatment of uterine fibroid. This agent acts on causing apoptosis of the muscle cells inside the tumor and reducing the tumor matrix in case of uterine fibroid. UPA at daily dose of 5 mg has been shown to decrease menstrual blood loss and reduce tumor size after 13 consecutive weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Ulipristal acetate (from Cenexi manufacturer, France) at daily dose of 5mg in 3 consecutive months course
My Duc Hospital
Ho Chi Minh City, Vietnam
Amenorrhea
Percentage of subjects achieve amenorrhea at the end of treatment. Amenorrhea is defined of 35 consecutive non-bleeding days, in which spotting is accepted.
Time frame: from first dose to the end of 3 consecutive months of treatment course
time from treatment to amenorrhea
the number of days from treatment initiation to the date that the subject has achieved amenorrhea.
Time frame: from first dose to the end of 3 consecutive months of treatment course
uterine fibroid size change
the total volume of the 3 largest uterine fibroids will be measured. Uterine fibroid size change will be calculated by percentage of the figure at the end of treatment in comparison to at baseline.
Time frame: from first dose to the end of 3 consecutive months of treatment course
pelvic pain control
Pelvic pain assessed by visual analogue score (VAS). The minimum score is 0, which means no pain at all. The maximum score is 10, which means unbearable pain. Higher scores mean worse outcome.
Time frame: from first dose to the end of 3 consecutive months of treatment course
adverse events
Percentage of participants have adverse events. Adverse events are defined as any undesirable experience occurring to a subject during a clinical trial, whether or not considered related to the intervention
Time frame: from first dose to the end of 3 consecutive months of treatment course, and the end of 3 months follow-up without treatment
Uterine fibroid symptom and health - related quality of life score change
Uterine Fibroid symptom and health - related quality of life questionnaire (UFS-QOL) consists of 37 questions to assess symptoms of uterine fibroid and their impacts on women's quality of life. Each answer is scored from 1 to 5, in which 1 equals not at all and 5 equals all of the time. The minimum score is 0 and the maximum score is 185. Higher scores mean worse outcome.
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Time frame: from first dose to the end of 3 consecutive months of treatment course
Abnormal endometrial features and thickness
Endometrial thickness is assessed via transvaginal ultrasound every month after initiation of treatment. Endometrial biopsy is performed at baseline and at the end of treatment.
Time frame: from first dose to the end of 3 consecutive months of treatment course
abnormal liver function test findings
Liver enzym (AST, ALT) is assessed every month after initiation of treatment. A two-fold or more increase in level of liver enzym is abnormal.
Time frame: from first dose to the end of 3 consecutive months of treatment course