VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept, 913-002

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, multicentre, cross-over proof of concept study to investigate the efficacy and safety of pre-emptive administration of repeated, oral doses of VA111913 TS for the alleviation of dysmenorrhoea.

• IRAS ID

  26099

• Contact name

  David J A Bell

• Eudract number

  2009-012457-37

• Research summary

  Dysmenorrhoea (painful menstrual cramps) can occur in any woman from the first time a young woman or girl menstruates to menopause. For many it can be debilitating and can lessen quality of life. The pain usually begins from hours before to just after onset of bleeding. Current medications on the market i.e. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and oral contraceptives are not completely effective for all women and sometimes do not provide satisfactory relief of symptoms particularly in women with moderate to severe dysmenorrhoea. Further treatment options are limited to stronger painkillers (opioids) or surgical intervention. There is therefore, a significant unmet medical need for the treatment of dysmenorrhoea, specifically for these women. Dysmenorrhoea is caused by increased contractions of the middle layer of the uterine wall, and reduced blood flow to the uterus. Therefore if a drug is able to reduce the hyperreactivity of the uterus to normal levels the pain experienced in dysmenorrhoea will be non-existent. The aim of this study is to obtain proof that dosing with this study drug before the onset of the pain and/or bleeding is effective and well-tolerated for women suffering from dysmenorrhoea.

• REC name

  HSC REC B

• REC reference

  09/NIR03/56

• Date of REC Opinion

  13 Aug 2009

• REC opinion

  Further Information Favourable Opinion