In short
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.
Key points
- Clinical trials of Ulipristal Acetate are focused on two very different questions. One Phase 3 trial studies people with symptomatic uterine fibroids and compares Ulipristal Acetate with surgery, looking at symptom severity, quality of life, and costs after 24 months. The other Phase 1 trial in healthy volunteers checks whether two tablet products are bioequivalent under fasting conditions. Together, these studies cover both patient outcomes and product comparison. The trial data include people with fibroids and healthy subjects.
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.
Both trials are interventional studies, which means the researchers give a treatment and measure the results.
Phase 3 study in uterine fibroids
The first trial is titled “Ulipristal versus surgery for symptomatic uterine fibroids” and is in Phase 3. It is authorised and includes 164 participants.
This study focuses on uterine fibroids, which are growths in the uterus that can cause symptoms. The trial compares Ulipristal Acetate with surgery, so it is looking at how well the study treatment performs against an operation-based approach.
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. The study also measures costs, including direct health care costs, loss of productivity from absenteeism, and patient costs.
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. It is completed and includes 60 healthy subjects.
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.
The trial uses blood-based measures called Cmax and AUC0-72 to assess bioequivalence under fasting conditions. These measures help researchers compare the amount of medicine in the body and how long it stays there.
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. The trial also looks at economic outcomes, such as treatment costs and work loss, which can matter to patients and health systems.
In the healthy volunteer study, the main outcome is not symptom relief but product comparison. The researchers use pharmacokinetic measures, which are blood test results that show how the body handles the tablet products.
Who can participate
The fibroid trial is for people with symptomatic uterine fibroids, so participants must have fibroids that are causing symptoms. The bioequivalence trial is for healthy subjects under fasting conditions, so it is not a patient study for a disease.
These two studies show that Ulipristal Acetate is being studied in both patient care and product testing settings.