Minimize Menorrhagia in Women With Von Willebrand Disease (NCT02606045) | Clinical Trial Compass
TerminatedPhase 3
Minimize Menorrhagia in Women With Von Willebrand Disease
Stopped: The study stopped early due to slow recruitment.
United States39 participantsStarted 2019-02-07
Plain-language summary
This is an outpatient, 24-week Phase III prospective, randomized, crossover trial comparing recombinant von Willebrand factor (rVWF) and tranexamic acid (TA, Lysteda®) to minimize menorrhagia in women with von Willebrand disease (VWD). The purpose of this Phase III multicenter prospective, randomized, crossover arm trial is to compare recombinant von Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in women with von Willebrand disease.
Who can participate
Age range13 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Adult females 13-45 years of age.
✓. Mild or moderate von Willebrand disease (VWF:RCo \<0.50 IU/ml, normal multimers, past bleeding)
✓. Menorrhagia defined as PBAC \>100 in at least one of the last two menstrual cycles.
✓. Regular menses, at least every 21-35 days.
✓. Willingness to have blood drawn
✓. No prior history of an allergic reaction or anaphylaxis to rVWF or TA.
✓. Willingness to avoid aspirin (ASA) and nonsteroidal anti-inflammatory agents (NSAIDS) during the study.
✓. Willingness to comply with randomization to rVWF or TA study arms.
Exclusion criteria
✕. Any bleeding disorder other than von Willebrand disease; or past thrombotic disease
✕. Pregnant or lactating, or use of hormones (other than progesterone-only), or combined oral contraceptives, and contraceptive implants in past 3 months.