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Ulipristal acetate

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Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months

Ulipristal acetate (from Cenexi manufacturer, France) at daily dose of 5mg in 3 consecutive months course

Ulipristal Acetate 5 mg

Dang Q Vinh, MD

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.

Ulipristal Acetate in Symptomatic Uterine Fibroid

The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid

Percentage of subjects achieve amenorrhea at the end of treatment. Amenorrhea is defined of 35 consecutive non-bleeding days, in which spotting is accepted.

the number of days from treatment initiation to the date that the subject has achieved amenorrhea.

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.

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.

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

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ulipristal Acetate in Symptomatic Uterine Fibroid	NCT04132349	Uterine Fibroid Heavy Menstrual...	Ulipristal Acet...	18 Years - 48 Years	Mỹ Đức Hospital
Ulipristal Acetate in Symptomatic Uterine Fibroid	NCT04132349	Uterine Fibroid Heavy Menstrual...	Ulipristal Acet...	18 Years - 48 Years	Mỹ Đức Hospital

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