VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Primary Dysmenorrhea Clinical Trial

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 TS for the Alleviation of Dysmenorrhoea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963053
• Other study ID #: 913-002
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2009
• Last updated: May 6, 2014
• Start date: August 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2014
• Source: Vantia Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Bio-Kinetic Europe Limited	Belfast
United States	Premier Research Group	Austin	Texas
United States	Pivotal Research Centers	Peoria	Arizona
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Vantia Ltd

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed using standard scoring system		3 months	No
Secondary	Safety assessed by laboratory findings, vital signs, ECGs and AEs		3 months	Yes
Secondary	Assessment of treatment effectiveness		3 months	No
Secondary	Requirement for rescue medication		3 months	No
Secondary	Assessment of menstrual bleeding		3 months	No
Secondary	PK assessments		3 months	No