VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Completed

• Source

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  Public Title	VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
  Acronym	Sorry, not currently available
  Source of Record URL	http://clinicaltrials.gov/show/NCT00963053

• Trial

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  Health Condition(s) or Problem	Primary Dysmenorrhea
  Lay Summary	The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea. (from ClinicalTrials.gov)
  Who can enter the trial	Inclusion Criteria: - Women between 18 and 35 years old - Not pregnant - History of primary dysmenorrhoea - Regular menstrual cycles - Signed informed consent Exclusion Criteria: - Known secondary dysmenorrhoea - Concomitant use of regular prescription or non prescription medications or herbal remedies - Any clinically significant medical history or active disease - Participation in another clinical study in the last 3 months - Contraindication to chosen rescue medications or allergy to their constituents - Other protocol defined eligibility criteria may apply
  Who cannot enter the trial	Inclusion Criteria: - Women between 18 and 35 years old - Not pregnant - History of primary dysmenorrhoea - Regular menstrual cycles - Signed informed consent Exclusion Criteria: - Known secondary dysmenorrhoea - Concomitant use of regular prescription or non prescription medications or herbal remedies - Any clinically significant medical history or active disease - Participation in another clinical study in the last 3 months - Contraindication to chosen rescue medications or allergy to their constituents - Other protocol defined eligibility criteria may apply
  What will happen	Drug; VA111913 TS and placebo; VA111913 TS twice daily for a maximum of 6 days during one menstrual cycle followed by placebo twice daily for up to a maximum of 6 days during a second menstrual cycle in a cross over design; VA111913 100mg twice daily; Starch pill
  Primary aim	Pain assessed using standard scoring system
  Secondary Aim	Safety assessed by laboratory findings, vital signs, ECGs and AEs; 3 months; Yes; Assessment of treatment effectiveness; 3 months; No; Requirement for rescue medication; 3 months; No; Assessment of menstrual bleeding; 3 months; No; PK assessments; 3 months; No
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Completed
  Nation	Northern Ireland
  Location	Belfast

• Contact

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  Contact for Public Queries	David Bell; Stephen E Daniels; Vernon Yamashiro; Louise Taber Principal Investigator; Principal Investigator; Principal Investigator; Principal Investigator Bio-Kinetic Europe Limited; PREMIER RESEARCH GROUP; Jean Brown Research; Pivotal Research Centers
  Contact for Scientific Queries	Sorry, not currently available