Abstract | OBJECTIVE: DESIGN: Randomized, double-blind, placebo-controlled, multicenter phase 3 study. SETTING: Hospitals and medical centers. PATIENT(S): INTERVENTION(S): Women were randomly assigned to 1 of 4 treatment arms, which were planned to comprise 2 treatment periods of 12 weeks, each with vilaprisan (2 mg/d) or placebo that were continuous or separated by a break of one bleed. MAIN OUTCOME MEASURE(S):
Amenorrhea (primary end point; <2 mL in the last 28 days of treatment) and heavy menstrual bleeding response (key secondary end point; <80 mL/cycle and >50% reduction in bleeding from baseline) were measured with the alkaline hematin method. Change in volume of the 3 largest fibroids from baseline to end of treatment was assessed by ultrasound. Safety was monitored throughout the study. RESULT(S): Overall, 75 women completed the first 12 weeks of treatment. Statistically significant and clinically meaningful differences were observed between the vilaprisan- and placebo-treated groups in both the full analysis and per-protocol sets. In the per-protocol set (n = 36 and n = 12 for the vilaprisan and placebo groups, respectively), amenorrhea was observed more frequently in women treated with vilaprisan than in those who received placebo (83.3% vs. 0%, P<.0001), with a median time to onset of 3 days in the vilaprisan group. Similarly, more vilaprisan- than placebo-treated women achieved a response in heavy menstrual bleeding (91.7% vs. 25.0%, P<.0001). Serious adverse events were reported for 22 (27.8%) of 79 women and were evenly distributed among the 4 groups receiving vilaprisan and/or placebo. None of these events led to study discontinuation or were related to the liver, and no new safety findings were identified compared with the earlier phase 2 ASTEROID studies. CONCLUSION(S): CLINICAL TRIAL REGISTRATION NUMBER: NCT03400943 (ClinicalTrials.gov).
|
Authors | Ayman Al-Hendy, Ying F Zhou, Thomas Faustmann, Esther Groettrup-Wolfers, Kaisa Laapas, Susanne Parke, Christian Seitz |
Journal | F&S science
(F S Sci)
Vol. 4
Issue 4
Pg. 317-326
(Nov 2023)
ISSN: 2666-335X [Electronic] United States |
PMID | 37437885
(Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article)
|
Copyright | Copyright © 2023 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved. |
Chemical References |
|
Topics |
- Female
- Humans
- Menorrhagia
(drug therapy, complications)
- Amenorrhea
(drug therapy, complications)
- Uterine Neoplasms
(complications, drug therapy)
- Leiomyoma
(complications, drug therapy)
- Steroids
|