VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
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
1 other identifier
interventional
146
2 countries
4
Brief Summary
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2009
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedMay 22, 2014
May 1, 2014
1.1 years
August 17, 2009
May 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain assessed using standard scoring system
3 months
Secondary Outcomes (5)
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
Study Arms (2)
VA111913 100mg twice daily
EXPERIMENTALStarch pill
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- Women between 18 and 35 years old
- Not pregnant
- History of primary dysmenorrhoea
- Regular menstrual cycles
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantia Ltdlead
Study Sites (4)
Pivotal Research Centers
Peoria, Arizona, 85381, United States
Premier Research Group
Austin, Texas, 78705, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Bio-Kinetic Europe Limited
Belfast, BT2 7BA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Bell
Bio-Kinetic Europe Limited
- PRINCIPAL INVESTIGATOR
Stephen E Daniels
Premier Research
- PRINCIPAL INVESTIGATOR
Vernon Yamashiro
Jean Brown Research
- PRINCIPAL INVESTIGATOR
Louise Taber
Pivotal Research Centers
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 21, 2009
Study Start
August 1, 2009
Primary Completion
September 1, 2010
Study Completion
November 1, 2010
Last Updated
May 22, 2014
Record last verified: 2014-05