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VA111913 for Primary Dysmenorrhoea
NCT00963053Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2009
- Primary completion
- Sep 2010
- Countries
- 2
- Sponsor
- Vantia Therapeutics
- Modality
- Small Molecules
- Drugs
- VA111913
- Conditions
- primary dysmenorrhea (PD)
01
Overview
Phase 2, randomised, double-blind trial in primary dysmenorrhea (PD) comparing VA111913 Sequence with Placebo Sequence (2 arms). Primary endpoint: Pain assessed using standard scoring system at 3 months. Started Aug 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
VA111913 Sequence
VA111913 then Placebo (or vice versa)
Placebo Sequence
Placebo then VA111913 (or vice versa)
03
Who it enrols
Women aged 18-35 with a history of primary dysmenorrhoea and regular menstrual cycles, excluding those with secondary dysmenorrhoea or concomitant medication use.
04
Endpoints
Primary
Pain assessed using standard scoring system
Secondary
Safety assessed by laboratory findings, vital signs, ECGs and AEs
Assessment of treatment effectiveness
Requirement for rescue medication
Assessment of menstrual bleeding
PK assessments
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