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
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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