Clinical Trial: VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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

Detailed Summary:

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


Sponsor: Vantia Ltd

Current Primary Outcome: Pain assessed using standard scoring system [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety assessed by laboratory findings, vital signs, ECGs and AEs [ Time Frame: 3 months ]
  • Assessment of treatment effectiveness [ Time Frame: 3 months ]
  • Requirement for rescue medication [ Time Frame: 3 months ]
  • Assessment of menstrual bleeding [ Time Frame: 3 months ]
  • PK assessments [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: Vantia Ltd

Dates:
Date Received: August 17, 2009
Date Started: August 2009
Date Completion:
Last Updated: May 6, 2014
Last Verified: May 2014