Back to resultsUlipristal Acetate in Symptomatic Uterine Fibroid
Primary Purpose
Uterine Fibroid, Heavy Menstrual Bleeding
Status
Terminated
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
Ulipristal Acetate 5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroid focused on measuring Ulipristal Acetate
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
Sites / Locations
- My Duc Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ullipristal Acetate
Arm Description
Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
time from treatment to amenorrhea
the number of days from treatment initiation to the date that the subject has achieved amenorrhea.
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.
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.
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04132349
Brief Title
Ulipristal Acetate in Symptomatic Uterine Fibroid
Official Title
The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Ulipristal Acetate was recalled
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mỹ Đức Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid, Heavy Menstrual Bleeding
Keywords
Ulipristal Acetate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ullipristal Acetate
Arm Type
Experimental
Arm Description
Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months
Intervention Type
Drug
Intervention Name(s)
Ulipristal Acetate 5 mg
Other Intervention Name(s)
Esmya
Intervention Description
Ulipristal acetate (from Cenexi manufacturer, France) at daily dose of 5mg in 3 consecutive months course
Primary Outcome Measure Information:
Title
Amenorrhea
Description
Percentage of subjects achieve amenorrhea at the end of treatment. Amenorrhea is defined of 35 consecutive non-bleeding days, in which spotting is accepted.
Time Frame
from first dose to the end of 3 consecutive months of treatment course
Secondary Outcome Measure Information:
Title
time from treatment to amenorrhea
Description
the number of days from treatment initiation to the date that the subject has achieved amenorrhea.
Time Frame
from first dose to the end of 3 consecutive months of treatment course
Title
uterine fibroid size change
Description
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.
Time Frame
from first dose to the end of 3 consecutive months of treatment course
Title
pelvic pain control
Description
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 Frame
from first dose to the end of 3 consecutive months of treatment course
Title
adverse events
Description
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
Time Frame
from first dose to the end of 3 consecutive months of treatment course, and the end of 3 months follow-up without treatment
Title
Uterine fibroid symptom and health - related quality of life score change
Description
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.
Time Frame
from first dose to the end of 3 consecutive months of treatment course
Title
Abnormal endometrial features and thickness
Description
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.
Time Frame
from first dose to the end of 3 consecutive months of treatment course
Title
abnormal liver function test findings
Description
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.
Time Frame
from first dose to the end of 3 consecutive months of treatment course
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dang Q Vinh, MD
Organizational Affiliation
Mỹ Đức Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
My Duc Hospital
City
Ho Chi Minh City
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Ulipristal Acetate in Symptomatic Uterine Fibroid
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