A leading clinical research center in Salt Lake City has joined an international trial program to test an experimental new drug designed to treat painful menstrual cramps, or dysmenorrhea, a condition that affects between 45 and 90 percent of women of childbearing age in the United States. Although not life threatening, dysmenorrhea can be debilitating and psychologically taxing and is one of the leading causes of absenteeism from work and school.
Current therapies for the condition (including NSAIDs and 'off label' oral contraceptives) are not completely effective for all women and sometimes do not provide satisfactory relief of symptoms, particularly in women with more severe pain. The investigational new drug, presently named VA111913, is designed to tackle the cause of the cramps that can leave some women bedridden, rather than just the symptoms.
The Jean Brown Research center is recruiting women of childbearing age who suffer from dysmenorrhea and normally take medicines to treat their menstrual cramps to take part in a clinical research trial. The trial will assess the effect that treatment with VA111913 has on pain experienced during menstruation, including the intensity and duration of the pain.
Menstrual cramps are caused by contractions of the uterus during menstruation. In earlier studies, VA111913 has been shown to control abnormal contraction of smooth muscle, such as that found in the uterus wall. By targeting receptors of a hormone called vasopressin it is hoped the investigational new drug will prove effective in controlling the abnormal contractions that cause period pain.
The study, which involves centers in the US and the UK, is a Phase II trial designed to show whether the drug is effective in treating menstrual cramps. Results from this trial are expected in 2010 and if it, and further studies, are successful, the drug could be available in four years.
Dr. Yamashiro, the physician leading the trial at Jean Brown Research, said, "Dysmenorrhea affects a large number of women and there is currently no targeted therapy to treat the condition. Earlier results with this investigational new drug showed effects on the contraction of smooth muscle and it is hoped that VA111913 could potentially offer an effective treatment to the many women whose lives are affected by this painful and debilitating condition."
Physicians and patients interested in learning more about this clinical trial can contact Jean Brown Research at 801-261-2000 for more information and to find out if they are initially eligible to screen for the study.
The trial is being sponsored by UK-based company Vantia Therapeutics, which discovered the new drug.