NCT00963053

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Vantia Ltd · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Dysmenorrhoea is suffered by between 50% and 90% of women of child bearing age. Up to 30% of these women are non-responsive to the currently prescribed therapies. As such it represents an area of unmet medical need. VA111913 inhibits vasopressin-induced contractions of human myometrial strips and human myometrial blood vessels in vitro. By this mechanism, it is anticipated that the pain of dysmenorrhoea, a condition in which myometrial tone and contractions are increased and blood flow to the uterus is decreased compared to normal, may be reduced. Subjects will be dosed with VA111913 TS and placebo in a cross over design during two consecutive menstrual cycles. They will be dosed for up to a maximum of 6 days, beginning 2 days before the onset of menstruation. Subjects will then assess the menstrual pain, bleeding and amount of analgesia required to treat symptoms during each cycle

Conditions

• Primary Dysmenorrhea

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2009-08-21
• Last updated: 2014-05-22

Locations

4 sites across 2 countries: United States, United Kingdom