Phase 3
N=157
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Leiomyoma · Uterine Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02147197 ↗Enrolled (actual)
157
Serious AEs
2.6%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment — 1.8; 47.2; 58.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ulipristal acetate (UPA) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Allergan
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment |
1.8; 47.2; 58.3 | — |
| PRIMARY Time to Absence of Bleeding on Treatment |
NA; NA; 9.5 | — |
| SECONDARY Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment |
0.0; 43.4; 58.3 | — |
| 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 Period |
34.51; 29.60; 28.15; 18.26; 53.00; 61.04 | — |
Summary
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Eligibility Criteria
Inclusion Criteria
- Pre-menopausal 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 rang
Data sourced from ClinicalTrials.gov (NCT02147197). 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.