Status:
COMPLETED
VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
Lead Sponsor:
Vantia Ltd
Conditions:
Primary Dysmenorrhea
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Detailed Description
Dysmenorrhoea is suffered by between 50% and 90% of women of child bearing age. Up to 30% of these women are non-responsive to the currently prescribed therapies. As such it represents an area of unme...
Eligibility Criteria
Inclusion
- Women between 18 and 35 years old
- Not pregnant
- History of primary dysmenorrhoea
- Regular menstrual cycles
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00963053
Start Date
August 1 2009
End Date
November 1 2010
Last Update
May 22 2014
Active Locations (4)
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1
Pivotal Research Centers
Peoria, Arizona, United States, 85381
2
Premier Research Group
Austin, Texas, United States, 78705
3
Jean Brown Research
Salt Lake City, Utah, United States, 84124
4
Bio-Kinetic Europe Limited
Belfast, United Kingdom, BT2 7BA