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Study Comparing Ulipristal Acetate and Surgery for Women with Symptomatic Uterine Fibroids

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called ulipristal acetate, which is available in the form of Esmya 5 mg tablets. The study is comparing this medication to standard surgical treatments for a condition known as uterine fibroids. Uterine fibroids are non-cancerous growths that develop in or on the uterus, often causing symptoms such as heavy menstrual bleeding, pain, and pressure in the pelvic area.

The purpose of the study is to evaluate how well ulipristal acetate improves the quality of life for women with symptomatic uterine fibroids compared to those who undergo surgery. Participants in the study will be randomly assigned to receive either the medication or a surgical treatment. The study will follow participants for a period of 24 months to assess changes in symptoms and overall quality of life. The study will also look at the costs associated with each treatment, including healthcare expenses and any impact on work productivity.

Throughout the study, researchers will monitor various aspects of health and well-being, such as pain levels, social participation, and sexual functioning. They will also track any changes in fibroid size, menstrual bleeding, and blood health, including liver function. The study aims to understand which treatment option is more effective and satisfactory for patients, as well as to identify any side effects or complications. The findings will help determine the best approach for managing uterine fibroids and improving patients' lives.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying that you have symptomatic uterine fibroids that require surgical treatment and that you are pre-menopausal and over 18 years of age.
You will be asked to complete a questionnaire about your symptoms and quality of life, known as the Uterine Fibroid Symptom-questionnaire (UFS-QOL).
Step 2
Randomization
After the initial assessment, you will be randomly assigned to one of two groups: the Ulipristal Acetate (UPA) group or the surgery group.
This process is random to ensure that the study results are unbiased.
Step 3
Treatment phase
If assigned to the UPA group, you will take Esmya 5 mg tablets orally. The dosage is one tablet per day.
The duration of the treatment with UPA will be determined by the study protocol and your healthcare provider.
If assigned to the surgery group, you will undergo a surgical procedure such as hysterectomy, myomectomy, or uterine artery embolization, as previously discussed with your healthcare provider.
Step 4
Follow-up assessments
Throughout the study, regular follow-up assessments will be conducted to monitor your health and the effects of the treatment.
You will be asked to complete the UFS-QOL questionnaire at various intervals to assess changes in your symptoms and quality of life.
Step 5
Final evaluation
At the end of the study period, a final evaluation will be conducted to assess the overall impact of the treatment on your symptoms and quality of life.
The study aims to measure outcomes at 24 months after randomization, including any changes in symptom severity and quality of life.

Who can join the trial?

5 criteria

You must have symptomatic fibroids that need surgical treatment. This means you have fibroids causing symptoms that require surgery, such as a hysterectomy (removal of the uterus), myomectomy (removal of fibroids), or uterine artery embolization (blocking blood supply to fibroids).
Conservative treatment, like medication, has either not worked for you or you do not want it.
You must be pre-menopausal, meaning you have not yet gone through menopause.
You must be over 18 years of age.
You must be female.

Who cannot join the trial?

3 criteria

Patients who are not female cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population may not be eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Albert Schweitzer Ziekenhuis
Dordrecht, The Netherlands
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Amphia Hospital
Breda, The Netherlands
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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Ulipristal is a medication used in this clinical trial to help manage symptoms caused by uterine fibroids, which are non-cancerous growths in the uterus. It works by altering the effects of the hormone progesterone in the body, which can help reduce the size of the fibroids and alleviate symptoms such as heavy menstrual bleeding and pelvic pain. This medication is being compared to standard surgical treatments to see how effective it is in improving the quality of life for women with symptomatic uterine fibroids.

Ulipristal Acetate

What is already known about the treatment

Ulipristal – Ulipristal is a medication administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating uterine fibroids, which are non-cancerous growths in the uterus that can cause symptoms like heavy menstrual bleeding and pain. The main therapeutic indication for ulipristal is to improve the quality of life for women with symptomatic uterine fibroids. At the molecular level, ulipristal works by modulating the activity of progesterone, a hormone involved in the menstrual cycle, which helps to reduce the size of fibroids and alleviate symptoms. It is classified pharmacologically as a selective progesterone receptor modulator (SPRM).

Investigated diseases

Uterine fibroids – Uterine fibroids are non-cancerous growths that develop in or on the uterus. They are composed of muscle and fibrous tissue and can vary in size. These fibroids often grow slowly and may not cause symptoms initially. As they enlarge, they can lead to symptoms such as heavy menstrual bleeding, pelvic pain, and pressure on the bladder or bowel. The growth of fibroids is influenced by hormonal factors, particularly estrogen and progesterone. Over time, they may remain stable, grow, or shrink, especially after menopause.