Primary Dysmenorrhea Clinical Trial
Official 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
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Status | Completed |
Enrollment | 146 |
Est. completion date | November 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Bio-Kinetic Europe Limited | Belfast | |
United States | Premier Research Group | Austin | Texas |
United States | Pivotal Research Centers | Peoria | Arizona |
United States | Jean Brown Research | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Vantia Ltd |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain assessed using standard scoring system | 3 months | No | |
Secondary | Safety assessed by laboratory findings, vital signs, ECGs and AEs | 3 months | Yes | |
Secondary | Assessment of treatment effectiveness | 3 months | No | |
Secondary | Requirement for rescue medication | 3 months | No | |
Secondary | Assessment of menstrual bleeding | 3 months | No | |
Secondary | PK assessments | 3 months | No |
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