Pivotal Research to study investigational drug for menstrual cramps

A leading clinical research center in Peoria has joined an international research program to study an investigational drug designed as a possible treatment for 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. It is hoped that the investigational drug, presently named VA111913, may prevent the cause of the cramps that can leave some women bedridden, rather than just treat the symptoms.

Pivotal Research is recruiting women of childbearing age who suffer from dysmenorrhea and normally take medicine to treat their menstrual cramps to take part in a research study. The study 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 contraction of the uterus during menstruation. In earlier studies, VA111913 has been shown to control abnormal contraction of smooth muscle tissue, such as that found in the uterus wall. By targeting receptors of a hormone called vasopressin, it is hoped that the investigational drug will prove effective in controlling the abnormal contractions that cause painful periods.

The study, which involves centers in the US and the UK, is a Phase II study designed to show whether the drug is effective in treating menstrual cramps. Results from this study are expected in 2010 and if it, and further studies are successful, the drug could be available in four years.

Dr. Louise Taber, the physician conducting the study at Pivotal Research, said: "Dysmenorrhea affects a large number of women and there is currently no targeted therapy to treat the cause of 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."