VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Study Overview
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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.

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

Official Title
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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

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Drug: VA111913 TS and placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VA111913 100mg twice daily<br> | Drug: VA111913 TS and placebo<br>* 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<br>|
| Placebo Comparator: Starch pill<br> | Drug: VA111913 TS and placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dysmenorrhoea, dysmenorrhea, pain, pre-emptive