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

NCT02255045 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-05-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255045 on ClinicalTrials.gov