Status:
COMPLETED
VA111913 TS: First in Human Study
Lead Sponsor:
Vantia Ltd
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the treatment of dysmenorrhea. This study is designed to investigate determine the safety, tolerability and pha...
Detailed Description
VA111913 TS is a selective V1a-receptor antagonist. The hypothesised mechanism of action of a V1a receptor antagonist in dysmenorrhea has been described in literature. Contractions of the uterine musc...
Eligibility Criteria
Inclusion
- Healthy females 18 to 45 years of age.
- Subjects must have a negative pregnancy test at screening and admission. Using acceptable form of contraceptive during and after study.
Exclusion
- Administration of any IMP within 12 weeks before entry to the study or any prescribed medicine within 14days of the study.
- Any clinically important medical disease, condition or abnormal laboratory test results.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00769964
Start Date
September 1 2008
End Date
March 1 2009
Last Update
June 25 2009
Active Locations (1)
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1
Charles River Clinical Services
Edinburgh, United Kingdom, EH33 2NE