Phase 3
Completed N=432
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Leiomyoma · Uterine Hemorrhage
Source: ClinicalTrials.gov NCT02147158 ↗
Enrolled (actual)
432
Serious AEs
2.1%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 — 0.0; 42.0; 54.8 percentage of participants
◆ Published Evidence
Established
40citations · ~5 / year
Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.
Summary
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Linked Publications (3)
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Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.
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Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL).
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Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 |
0.0; 42.0; 54.8 | — |
| PRIMARY Time to Absence of Bleeding on Treatment During Treatment Course 1 |
NA; NA; 36.0 | — |
| SECONDARY Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1 |
0.0; 34.6; 55.4 | — |
| SECONDARY Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2 |
8.0; 40.5; 57.3 | — |
| SECONDARY Time to Absence of Bleeding on Treatment During Treatment Course 2 |
NA; NA; 7.5 | — |
| SECONDARY Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1 |
28.70; 27.52; 33.24; 14.25; 50.19; 54.73 | — |
Eligibility Criteria
Inclusion Criteria
- Premenopausal women, 18-50 years, inclusive.
- Cyclic abnormal uterine bleeding (heavy or prolonged).
- Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
- Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
- Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia.
Exclusion Criteria
- History of uterine surgery that would interfere with the study endpoints.
- Known coagulation disorder including bleeding disorder or clotting disorder.
- History of, or current uterine, cervix, ovarian, or breast cancer.
- Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal range.
Data sourced from ClinicalTrials.gov (NCT02147158) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.