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VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

NCT00963053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2014-05-22

No results posted yet for this study

Summary

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

Conditions

  • Primary Dysmenorrhea

Interventions

DRUG

VA111913 TS and placebo

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

Sponsors & Collaborators

  • Vantia Ltd

    lead INDUSTRY

Principal Investigators

  • David Bell · Bio-Kinetic Europe Limited

  • Stephen E Daniels · Premier Research

  • Vernon Yamashiro · Jean Brown Research

  • Louise Taber · Pivotal Research Centers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-09-30
Completion
2010-11-30

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00963053 on ClinicalTrials.gov