Uterine FibroidPhase 4NCT04132349
Ulipristal Acetate in Symptomatic Uterine Fibroid
A Phase 4 study testing Ulipristal Acetate 5 mg in people with Uterine Fibroid and Heavy Menstrual Bleeding, run by Mỹ Đức Hospital at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Uterine Fibroid, Heavy Menstrual Bleeding
- What is being tested?
- Ulipristal Acetate 5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteVietnam
- Study dates
- 23 Oct 2019to 1 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterine Fibroid, Heavy Menstrual Bleeding
- Being tested
- Ulipristal Acetate 5 mg
- Keywords
- Ulipristal Acetate
- Medical subject headings
- Leiomyoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal Acetate 5 mgDrug
Also called Esmya
Ulipristal acetate (from Cenexi manufacturer, France) at daily dose of 5mg in 3 consecutive months course
| Study group | Role | What they receive |
|---|---|---|
| Ullipristal Acetate | Experimental | Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months Receives: Drug: Ulipristal Acetate 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from first dose to the end of 3 consecutive months of treatment course
Secondary outcomes (7)
time from treatment to amenorrhea
the number of days from treatment initiation to the date that the subject has achieved amenorrhea.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from first dose to the end of 3 consecutive months of treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start23 Oct 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: Ulipristal Acetate was recalled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dang Q Vinh, MD, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132349
- Sponsor's protocol ID
- CS/BVMD/19/12
- Status last verified
- Apr 2020
- First submitted
- 15 Oct 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid
- ClinicalTrials.gov ID
- NCT04132349
- Acronym / sponsor ID
- CS/BVMD/19/12
- Conditions
- Uterine Fibroid, Heavy Menstrual Bleeding
- Keywords
- Ulipristal Acetate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ulipristal Acetate was recalled
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Ullipristal Acetate | Experimental | Drug: Ulipristal Acetate 5 mgWomen with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulipristal Acetate 5 mgAlso: EsmyaUlipristal acetate (from Cenexi manufacturer, France) at daily dose of 5mg in 3 consecutive months course | Drug | Ullipristal Acetate |
Primary outcome
Amenorrhea
Time frame: 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.
7 secondary outcomes
time from treatment to amenorrhea
Time frame: from first dose to the end of 3 consecutive months of treatment course
uterine fibroid size change
Time frame: from first dose to the end of 3 consecutive months of treatment course
pelvic pain control
Time frame: from first dose to the end of 3 consecutive months of treatment course
adverse events
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
Uterine fibroid symptom and health - related quality of life score change
Time frame: from first dose to the end of 3 consecutive months of treatment course
Abnormal endometrial features and thickness
Time frame: from first dose to the end of 3 consecutive months of treatment course
abnormal liver function test findings
Time frame: from first dose to the end of 3 consecutive months of treatment course
Results and safety
The study was stopped early (reason given: Ulipristal Acetate was recalled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dang Q Vinh, MD principal investigator
Mỹ Đức Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ulipristal Acetate 5 mg in people with Uterine Fibroid and Heavy Menstrual Bleeding, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Ulipristal Acetate was recalled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amenorrhea (time frame: from first dose to the end of 3 consecutive months of treatment course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.