Overview

VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vantia Ltd
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