Clinical trial NCT00963053: VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Dysmenorrhea
Keywords: dysmenorrhoea
dysmenorrhea
pain
pre-emptive
Lead sponsor: Vantia Ltd
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessed using standard scoring system
timeFrame: 3 months
Secondary outcomes:
measure: Safety assessed by laboratory findings, vital signs, ECGs and AEs
timeFrame: 3 months
measure: Assessment of treatment effectiveness
timeFrame: 3 months
measure: Requirement for rescue medication
timeFrame: 3 months
measure: Assessment of menstrual bleeding
timeFrame: 3 months
measure: PK assessments
timeFrame: 3 months
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Austin
country: United States
facility: Premier Research Group
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Belfast
country: United Kingdom
facility: Bio-Kinetic Europe Limited
Study officials:
affiliation: Bio-Kinetic Europe Limited
name: David Bell
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Research Group plc
name: Stephen E Daniels
role: PRINCIPAL_INVESTIGATOR
affiliation: Jean Brown Research
name: Vernon Yamashiro
role: PRINCIPAL_INVESTIGATOR
affiliation: Pivotal Research Centers
name: Louise Taber
role: PRINCIPAL_INVESTIGATOR
References: