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

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

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Drug: VA111913 TS and placebo

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

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT2 7BA
    • Bio-Kinetic Europe Limited
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Centers
  • Texas
    • Austin, Texas, United States, 78705
      • Premier Research Group
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Starch pill	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
Experimental: VA111913 100mg twice daily	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain assessed using standard scoring system	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vantia Ltd
• Investigators: Principal Investigator: David Bell, Bio-Kinetic Europe Limited; Principal Investigator: Stephen E Daniels, Premier Research Group plc; Principal Investigator: Vernon Yamashiro, Jean Brown Research; Principal Investigator: Louise Taber, Pivotal Research Centers

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: August 17, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (Estimate): August 21, 2009

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 6, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: pain; dysmenorrhoea; dysmenorrhea; pre-emptive
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 913-002