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Ulipristal Acetate

Clinical trials of Ulipristal Acetate are studying its use in uterine fibroids and testing whether two tablet products act the same in healthy people. The trials look at patient-reported symptom relief, quality of life, costs, and bioequivalence measures. They include people with uterine fibroids and healthy volunteers.

Table of Contents

Trial overview

Two clinical trials are listed for Ulipristal Acetate. One trial studies people with uterine fibroids and compares treatment with surgery, while the other tests whether two tablet products are similar in healthy subjects.[1][2]

Both trials are interventional studies, which means the researchers give a treatment and measure the results.[1][2]

Phase 3 study in uterine fibroids

The first trial is titled “Ulipristal versus surgery for symptomatic uterine fibroids” and is in Phase 3.[1] It is authorised and includes 164 participants.[1]

This study focuses on uterine fibroids, which are growths in the uterus that can cause symptoms.[1] The trial compares Ulipristal Acetate with surgery, so it is looking at how well the study treatment performs against an operation-based approach.[1]

The main patient outcome is the UFS-QOL, a questionnaire about fibroid symptoms and quality of life, with a symptom severity score measured 24 months after randomization.[1] The study also measures costs, including direct health care costs, loss of productivity from absenteeism, and patient costs.[1]

Phase 1 bioequivalence study in healthy subjects

The second trial is titled “Bioequivalence of Ulipristal 30 mg Tablets in Healthy Subjects Under Fasting Conditions” and is in Phase 1.[2] It is completed and includes 60 healthy subjects.[2]

This study does not target a disease. Instead, it compares two tablet products to show whether they are bioequivalent, meaning they behave in a similar way in the body.[2]

The trial uses blood-based measures called Cmax and AUC0-72 to assess bioequivalence under fasting conditions.[2] These measures help researchers compare the amount of medicine in the body and how long it stays there.[2]

Main outcomes and what they mean

In the fibroid study, the main outcome is patient-reported symptom severity and quality of life, which helps show how the condition affects daily life.[1] The trial also looks at economic outcomes, such as treatment costs and work loss, which can matter to patients and health systems.[1]

In the healthy volunteer study, the main outcome is not symptom relief but product comparison.[2] The researchers use pharmacokinetic measures, which are blood test results that show how the body handles the tablet products.[2]

Who can participate

The fibroid trial is for people with symptomatic uterine fibroids, so participants must have fibroids that are causing symptoms.[1] The bioequivalence trial is for healthy subjects under fasting conditions, so it is not a patient study for a disease.[2]

These two studies show that Ulipristal Acetate is being studied in both patient care and product testing settings.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
2024-512602-26-00Phase 3Uterine fibroidsAuthorised164
2023-504258-36-00Phase 1No medical condition / healthy subjectsCompleted60

FAQ

  • What conditions are being studied in Ulipristal Acetate trials? The trials study uterine fibroids and bioequivalence in healthy subjects. One trial focuses on symptoms and quality of life in people with fibroids, while the other is in healthy volunteers.
  • Who can take part in these trials? One trial enrolls people with symptomatic uterine fibroids. The other trial enrolls healthy subjects under fasting conditions.
  • What phases are the Ulipristal Acetate trials? The fibroid trial is Phase 3, which usually means a later-stage study in patients. The bioequivalence trial is Phase 1, which is an early study in healthy people.
  • What are the main outcomes being measured? The fibroid trial measures symptom severity, quality of life, and costs after 24 months. The healthy volunteer trial measures Cmax and AUC0-72, which are blood test measures used to compare how much and how fast the medicine enters the body.
  • Are these trials testing the same goal? No. One trial compares Ulipristal Acetate with surgery for fibroids, and the other checks whether two tablet products are bioequivalent. Bioequivalence means they are expected to work in a similar way in the body.

Ongoing Clinical Trials on Ulipristal Acetate

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

    Recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • Bioequivalence Study of Ulipristal Acetate 30 mg Tablet in Healthy Subjects Under Fasting Conditions

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Portugal

Glossary

  • Uterine fibroids: Non-cancerous growths in the uterus. They can cause symptoms such as pain, heavy bleeding, or pressure.
  • Symptomatic: Having signs or problems caused by a condition. In this data, it means fibroids that are causing symptoms.
  • Phase 1: An early clinical trial phase, often done in healthy volunteers to study how a product behaves in the body.
  • Phase 3: A later trial phase that usually includes more patients and looks at how well a treatment works in real-life use.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Bioequivalence: A comparison showing that two medicine products act in a similar way in the body.
  • Cmax: The highest level of a medicine measured in the blood after it is taken.
  • AUC0-72: A blood test measure showing total medicine exposure over 72 hours.
  • UFS-QOL: Uterine Fibroid Symptom and Quality of Life questionnaire. It asks patients about symptoms and how fibroids affect daily life.
  • Symptom severity score: A score that shows how serious the symptoms are. A higher or lower score can help show whether symptoms improved.

References

  1. https://clinicaltrials.gov/study/2024-512602-26-00
  2. https://clinicaltrials.gov/study/2023-504258-36-00