VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept | Completed
VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Primary Dysmenorrhea
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT00963053
Primary Trial ID Number
Summary
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Research Details
  • 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
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : VA111913 TS and placebo

Study Arm Groups : VA111913 100mg twice daily, Starch pill

Intervention Type
See Interventions above
Primary Outcome Measures
  • Pain assessed using standard scoring system; 3 months
Secondary Outcome Measures
  • Safety assessed by laboratory findings, vital signs, ECGs and AEs; 3 months; Assessment of treatment effectiveness; 3 months; Requirement for rescue medication; 3 months; Assessment of menstrual bleeding; 3 months; PK assessments; 3 months
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Female
Age Range
18 Years - 35 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
GBR003
Belfast
BT2 7BA
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, United Kingdom
Scientific 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 TS for the Alleviation of Dysmenorrhoea
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
913-002
Sponsor(s)
Vantia Ltd
Key Dates

Recruitment Start Date

Aug 2009

Recruitment End Date

Sep 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

17 Aug 2009

Last Updated

06 May 2014