Ulipristal Acetate in Symptomatic Uterine Fibroid

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

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.

Study Overview

• Status: Terminated
• Conditions: Uterine Fibroid; Heavy Menstrual Bleeding
• Intervention / Treatment: Drug: Ulipristal Acetate 5 mg

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • My Duc Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ullipristal Acetate; Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months	Drug: Ulipristal Acetate 5 mg; Ulipristal acetate (from Cenexi manufacturer, France) at daily dose of 5mg in 3 consecutive months course; Other Names: Esmya

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Mỹ Đức Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Ulipristal Acetate
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Leiomyoma; Myofibroma; Menorrhagia; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Ulipristal acetate
• Other Study ID Numbers: CS/BVMD/19/12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No