VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Vantia

Status and phase

Completed

Phase 2

Conditions

Primary Dysmenorrhea

Treatments

Drug: VA111913 TS and placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00963053

913-002

Details and patient eligibility

About

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

Full 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

Enrollment

146 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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