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Search / Trial NCT00963053

VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Launched by VANTIA LTD · Aug 20, 2009

Trial Information

Current as of May 21, 2025

Completed

Keywords

Dysmenorrhoea Dysmenorrhea Pain Pre Emptive

ClinConnect Summary

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 an...

Gender

FEMALE

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

About Vantia Ltd

Vantia Ltd. is a pioneering clinical trial sponsor dedicated to advancing innovative therapies through rigorous research and development. With a focus on high-quality clinical trials, Vantia Ltd. collaborates with healthcare professionals and institutions to bring cutting-edge treatments to market. The company prioritizes patient safety and scientific integrity, leveraging a team of experienced professionals to ensure compliance with regulatory standards and optimize trial outcomes. Through its commitment to excellence, Vantia Ltd. aims to make a meaningful impact on global health by accelerating the development of novel medical solutions.

Locations

Peoria, Arizona, United States

Salt Lake City, Utah, United States

Belfast, , United Kingdom

Austin, Texas, United States

Patients applied

0 patients applied

Trial Officials

David Bell

Principal Investigator

Bio-Kinetic Europe Limited

Stephen E Daniels

Principal Investigator

Premier Research Group plc

Vernon Yamashiro

Principal Investigator

Jean Brown Research

Louise Taber

Principal Investigator

Pivotal Research Centers

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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