CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 68 enrolled
Drug / intervention
Meloxicam +3 moredrug
Likely dose
Diclofenac Potassium 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02255045
NCT02255045Phase 3Completed

Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age

Laboratorios Andromaco S.A.·interventional·Posted Oct 2, 2014·Updated May 3, 2019

In Brief

A Phase 3 clinical trial evaluating Meloxicam, Diclofenac Potassium, and 2 other interventions for Dysmenorrhea. Completed, enrolled 68 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysmenorrhea
CountriesChile
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2, 2014
Enrollment StartJun 27, 2014
Primary CompletionFeb 21, 2016
Study CompletionMar 16, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.8 years ago

Interventions

Meloxicamdrug

1 Meloxicam Vaginal Ring (MVR) for 4-6 days

Diclofenac Potassiumdrug

1 tablet 50 mg diclofenac every 12 hours for 4-6 days

Placebo Oraldrug

1 placebo tablet every 12 hours for 4-6 days

Placebo Vaginaldrug

1 placebo vaginal ring for 4-6 days