VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-11-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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VA111913 100mg twice daily

Group Type EXPERIMENTAL

VA111913 TS and placebo

Intervention Type DRUG

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

Starch pill

Group Type PLACEBO_COMPARATOR

VA111913 TS and placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No