Clinical trial NCT04132349: Ulipristal Acetate in Symptomatic Uterine Fibroid
Official title: The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Uterine Fibroid
Heavy Menstrual Bleeding
Keywords: Ulipristal Acetate
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: TREATMENT

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 dose of 5mg.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Amenorrhea
timeFrame: from first dose to the end of 3 consecutive months of treatment course
Secondary outcomes:
measure: time from treatment to amenorrhea
timeFrame: from first dose to the end of 3 consecutive months of treatment course
measure: uterine fibroid size change
timeFrame: from first dose to the end of 3 consecutive months of treatment course
measure: pelvic pain control
timeFrame: from first dose to the end of 3 consecutive months of treatment course
measure: adverse events
timeFrame: from first dose to the end of 3 consecutive months of treatment course, and the end of 3 months follow-up without treatment
measure: Uterine fibroid symptom and health - related quality of life score change
timeFrame: from first dose to the end of 3 consecutive months of treatment course
measure: Abnormal endometrial features and thickness
timeFrame: from first dose to the end of 3 consecutive months of treatment course
measure: abnormal liver function test findings
timeFrame: from first dose to the end of 3 consecutive months of treatment course
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
Study officials:
affiliation: Mỹ Đức Hospital
name: Dang Q Vinh, MD
role: PRINCIPAL_INVESTIGATOR
References: