drugset / Trial / NCT02255045
Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea
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
Publications
- Background Marjoribanks J, Proctor M, Farquhar C, Derks RS. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001751. doi: 10.1002/14651858.CD001751.pub2.
- Background Harel Z. Cyclooxygenase-2 specific inhibitors in the treatment of dysmenorrhea. J Pediatr Adolesc Gynecol. 2004 Apr;17(2):75-9. doi: 10.1016/j.jpag.2004.01.002.
- Background de Mello NR, Baracat EC, Tomaz G, Bedone AJ, Camargos A, Barbosa IC, de Souza RN, Rumi DO, Martinez Alcala FO, Velasco JA, Cortes RJ. Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea. Acta Obstet Gynecol Scand. 2004 Jul;83(7):667-73. doi: 10.1111/j.0001-6349.2004.00433.x.
- Background Chantler I, Mitchell D, Fuller A. The effect of three cyclo-oxygenase inhibitors on intensity of primary dysmenorrheic pain. Clin J Pain. 2008 Jan;24(1):39-44. doi: 10.1097/AJP.0b013e318156dafc.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diclofenac | Other / unclassified | 50 mg | Oral |
| Subject | Meloxicam | Small molecule | 2.4 g | Other |
| Subject | Meloxicam | Small molecule | 3 g | Other |