VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept | Completed
VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
Health Conditions
  • Primary Dysmenorrhea
Completed
Recruitment Status
NCT00963053
Primary Trial ID Number
Summary
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Primary Outcome Measures
  • Pain assessed using standard scoring system; 3 months
Secondary Outcome Measures
  • Safety assessed by laboratory findings, vital signs, ECGs and AEs; 3 months; Assessment of treatment effectiveness; 3 months; Requirement for rescue medication; 3 months; Assessment of menstrual bleeding; 3 months; PK assessments; 3 months
Research Question
  • The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; United Kingdom
Participant Sex
Female
Participant Age Range
18 Years to 35 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
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Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
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]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific 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
Secondary Trial Identifying Number
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Website
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Study Funded By
Vantia Ltd
Funder Type
Sorry, this information is not available
Study Sponsored By
Vantia Ltd
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

17 Aug 2009

Last Updated

06 May 2014

Date Record Refreshed on UKCTG

31 Jul 2015