Trial reportWomen's health (London, England)
Safety and efficacy of vilaprisan in Japanese women with fibroids: The Phase 3 ASTEROID 8 trial.
Trial report in Women's health (London, England). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03476928 (An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVilaprisan is a selective progesterone receptor modulator with demonstrated efficacy in the management of uterine fibroids (UFs).
objectivesTo evaluate the safety and efficacy of vilaprisan in Japanese women with UFs and heavy menstrual bleeding (HMB).
designOpen-label, parallel-group, Phase 3 randomized clinical trial.
methodsJapanese women with UFs and HMB were randomly assigned 1:1 to receive vilaprisan (2 mg/day) for either four treatment periods (TPs) of 12 weeks each separated by one bleeding period (Arm A1) or two TPs of 24 weeks each separated by two bleeding periods (Arm A2). The primary endpoint was the incidence of treatment-emergent adverse events (TEAEs).
resultsOf 179 women enrolled, 151 were included in the full analysis set and 148 in the safety analysis set. TEAEs occurred in 79.1% of women, with the majority being mild; events were evenly distributed across both treatment arms. Study drug-related TEAEs were observed in 44.6% of women, and serious TEAEs were reported in 3.4% of women. During the treatment phase, the mean (standard deviation) number of bleeding days per 28 days decreased to 1.40 (1.34) days in Arm A1 and 1.42 (0.82) days in Arm A2 from respective baseline values of 5.1 (2.3) and 5.2 (2.0) days. Median time to onset of amenorrhea was 4 days in TP1 in both arms, and 4 days in TP2 in Arm A1. Absence of bleeding for the last 28 days was more common in TP1 (Arm A1: 91.89%, Arm A2: 89.19%) than TP2 (Arm A1: 80.85%, Arm A2: 85.71%).
conclusionIn this study, vilaprisan 2 mg/day was found to be well tolerated and efficacious in Japanese women with UFs and HMB. However, the study sponsor later terminated the overall clinical development of vilaprisan due to potential safety concerns from long-term rodent studies. REGISTRATION: The ASTEROID 8 study was registered at https://clinicaltrials.gov/ (registration number: NCT03476928).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.