NCT02255045

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Laboratorios Andromaco S.A. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	Meloxicam	1 Meloxicam Vaginal Ring (MVR) for 4-6 days
DRUG	Diclofenac Potassium	1 tablet 50 mg diclofenac every 12 hours for 4-6 days
DRUG	Placebo Oral	1 placebo tablet every 12 hours for 4-6 days
DRUG	Placebo Vaginal	1 placebo vaginal ring for 4-6 days

Timeline

• Start date: 2014-06-27
• Primary completion: 2016-02-21
• Completion: 2016-03-16
• First posted: 2014-10-02
• Last updated: 2019-05-03

Locations

1 site across 1 country: Chile