Health-related quality of life with ulipristal acetate for treatment of uterine leiomyomas: A randomized controlled trial

Andrea S. Lukes*, David Soper, Amanda Harrington, Vilma Sniukiene, Yifan Mo, Patrick Gillard, Lee Shulman

*Corresponding author for this work

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

OBJECTIVE:To investigate effects of ulipristal acetate on health-related quality of life (QOL) and symptom severity in women with symptomatic uterine leiomyomas and abnormal uterine bleeding.METHODS:Women were randomized to ulipristal (5 mg, 10 mg) or placebo in two phase 3, multicenter, double-blind, placebo-controlled trials (VENUS I and II). Health-related QOL and symptom severity were assessed at baseline, and over one (VENUS I and II) and two (VENUS II) 12-week treatment courses using the Uterine Fibroid Symptom Health-Related Quality of Life questionnaire. In pooled VENUS I and II data, change from baseline to the end of the first course for each Uterine Fibroid Symptom Health-Related Quality of Life scale was analyzed, including a Revised Activities subscale that measured physical and social activities. The proportion of women achieving meaningful change in the Symptom Severity (20 or more points), Health-Related QOL Total (20 or more points), and Revised Activities (30 or more points) scales was calculated. In VENUS II data, change from baseline to the end of each course in each scale was analyzed for each treatment arm.RESULTS:In pooled analyses, the intent-to-treat population included 589 patients (placebo, n=169; ulipristal 5 mg, n=215; ulipristal 10 mg, n=205). Significantly greater improvements from baseline in all Uterine Fibroid Symptom Health-Related Quality of Life scales were observed with both ulipristal doses compared with placebo (P<.001). A meaningful change in Revised Activities was achieved by 51 patients receiving placebo (34.9%), compared with 144 (73.5%; OR 5.0 [97.5% CI 2.9-8.6]) and 141 (80.6%; OR 7.9 [97.5% CI 4.3-14.6]) patients receiving ulipristal 5 mg, and 10 mg, respectively. In VENUS II, at end of courses 1 and 2, both ulipristal doses demonstrated significant improvements from baseline compared with placebo for all Uterine Fibroid Symptom Health-Related Quality of Life scales (P<.01). Mean Revised Activities scores showed that beneficial ulipristal effects were maintained in course 2, and improvements occurred on switching to ulipristal; results for other scales were similar.CONCLUSION:Ulipristal was associated with significant improvements in health-related QOL and symptom severity compared with placebo for women with symptomatic uterine leiomyomas.CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT02147197 and NCT02147158.FUNDING SOURCE:Allergan plc, Dublin, Ireland.

Original languageEnglish (US)
Pages (from-to)869-878
Number of pages10
JournalObstetrics and gynecology
Volume133
Issue number5
DOIs
StatePublished - May 1 2019

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Fingerprint Dive into the research topics of 'Health-related quality of life with ulipristal acetate for treatment of uterine leiomyomas: A randomized controlled trial'. Together they form a unique fingerprint.

  • Cite this