Ulipristal Acetate in Symptomatic Uterine Fibroid

Uterine Fibroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04132349
• Other study ID #: CS/BVMD/19/12
• Status: Terminated
• Phase: Phase 4
• Start date: October 23, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: M? Ð?c Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Leiomyoma
• Menorrhagia
• Uterine Fibroid

Intervention

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

Locations

Country	Name	City	State
Vietnam	My Duc Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from first dose to the end of 3 consecutive months of treatment course
Secondary	time from treatment to amenorrhea	the number of days from treatment initiation to the date that the subject has achieved amenorrhea.	from first dose to the end of 3 consecutive months of treatment course
Secondary	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.	from first dose to the end of 3 consecutive months of treatment course
Secondary	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.	from first dose to the end of 3 consecutive months of treatment course
Secondary	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	from first dose to the end of 3 consecutive months of treatment course, and the end of 3 months follow-up without treatment
Secondary	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.	from first dose to the end of 3 consecutive months of treatment course
Secondary	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.	from first dose to the end of 3 consecutive months of treatment course
Secondary	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.	from first dose to the end of 3 consecutive months of treatment course