Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea
NCT ID: NCT02255045
Last Updated: 2019-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
68 participants
INTERVENTIONAL
2014-06-27
2016-03-16
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Dose 1 of meloxicam in vaginal ring
2.4 g of meloxicam in a vaginal ring
Meloxicam
1 Meloxicam Vaginal Ring (MVR) for 4-6 days
Placebo Oral
1 placebo tablet every 12 hours for 4-6 days
Dose 2 of meloxicam in vaginal ring
3.0 g of meloxicam in a vaginal ring
Meloxicam
1 Meloxicam Vaginal Ring (MVR) for 4-6 days
Placebo Oral
1 placebo tablet every 12 hours for 4-6 days
Oral non-steroidal anti-inflammatory drug
Diclofenac potassium
Diclofenac Potassium
1 tablet 50 mg diclofenac every 12 hours for 4-6 days
Placebo Vaginal
1 placebo vaginal ring for 4-6 days
Placebo vaginal ring and oral pill
Placebo vaginal ring and placebo oral pill
Placebo Oral
1 placebo tablet every 12 hours for 4-6 days
Placebo Vaginal
1 placebo vaginal ring for 4-6 days
Interventions
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Meloxicam
1 Meloxicam Vaginal Ring (MVR) for 4-6 days
Diclofenac Potassium
1 tablet 50 mg diclofenac every 12 hours for 4-6 days
Placebo Oral
1 placebo tablet every 12 hours for 4-6 days
Placebo Vaginal
1 placebo vaginal ring for 4-6 days
Eligibility Criteria
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Inclusion Criteria
* Primary dysmenorrhea on 3 previous months,
* With tubal ligation or users of condom for contraception,
* Hemoglobin of at least 11 g/dl,
* Safety blood analysis in normal levels
Exclusion Criteria
* Users of hormonal contraceptives (2 months prior to the study) or intrauterine devices (IUDs) (1 month prior the study).
* Allergy to any anti-inflammatory drug including meloxicam or diclofenac.
* Allergy to silicon.
* Pregnant or in lactation.
* Women with untreated or decompensated endocrine disorders
18 Years
45 Years
FEMALE
Yes
Sponsors
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Laboratorios Andromaco S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Grünenthal Study Director
Role: STUDY_DIRECTOR
Grünenthal GmbH
Locations
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Instituto Chileno de Medicina Reproductiva (ICMER)
Santiago, , Chile
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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AVM002
Identifier Type: -
Identifier Source: org_study_id
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