VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Dysmenorrhea

In brief

The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.

Key facts

Study ID

NCT00963053

Run by

Vantia Ltd

People needed

146

Starts

2009-08-01

Expected to finish

2010-11-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Pivotal Research Centers — Peoria, Arizona, United States
• Premier Research Group — Austin, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States
• Bio-Kinetic Europe Limited — Belfast, United Kingdom

Full record on ClinicalTrials.gov

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