Ulipristal Acetate in Symptomatic Uterine Fibroid

Phase 4

Terminated

• Conditions: Uterine Fibroid; Heavy Menstrual Bleeding
• Interventions: Drug: Ulipristal Acetate 5 mg

• Registration Number: NCT04132349
• Lead Sponsor: Mỹ Đức Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2019-10-23
• Status Verified: 2020-04
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ullipristal Acetate	Ulipristal Acetate 5 mg	Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months

Primary Outcome Measures

Name	Time	Method
Amenorrhea	from first dose to the end of 3 consecutive months of treatment course	Percentage of subjects achieve amenorrhea at the end of treatment. Amenorrhea is defined of 35 consecutive non-bleeding days, in which spotting is accepted.

Secondary Outcome Measures

Name	Time	Method
Abnormal endometrial features and thickness	from first dose to the end of 3 consecutive months of treatment course	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.
adverse events	from first dose to the end of 3 consecutive months of treatment course, and the end of 3 months follow-up without treatment	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 score change	from first dose to the end of 3 consecutive months of treatment course	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.
uterine fibroid size change	from first dose to the end of 3 consecutive months of treatment course	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.
abnormal liver function test findings	from first dose to the end of 3 consecutive months of treatment course	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.
pelvic pain control	from first dose to the end of 3 consecutive months of treatment course	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 from treatment to amenorrhea	from first dose to the end of 3 consecutive months of treatment course	the number of days from treatment initiation to the date that the subject has achieved amenorrhea.

Trial Locations

Locations (1)

My Duc Hospital; 🇻🇳 Ho Chi Minh City, Vietnam