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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00963053
Other study ID # 913-002
Secondary ID
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


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
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