drugset / Trial / NCT02255045

Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea

NCT02255045

Phase 2/3 Completed 68 enrolled Laboratorios Andromaco S.A.
RandomizedCrossoverTriple-blindTreatment

Summary

The investigators propose that the sustained administration of a vaginal ring would have a better response with respect to pain and a better safety profile than the oral administration of a non-steroidal anti-inflammatory drug. To assess the relief of the symptoms associated with dysmenorrhea, a specific survey was elaborated that also includes a Visual Analog Scale (VAS) to objectify and measure dysmenorrhea as is the case with McGill's Pain Questionnaire (MPQ).

Timeline

Start
2014-06-27
Primary completion
2016-02-21
Completion
2016-03-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diclofenac Other / unclassified 50 mg Oral
Subject Meloxicam Small molecule 2.4 g Other
Subject Meloxicam Small molecule 3 g Other

Indications