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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 of meloxicam in vaginal ring | Experimental | 2.4 g of meloxicam in a vaginal ring |
|
| Dose 2 of meloxicam in vaginal ring | Experimental | 3.0 g of meloxicam in a vaginal ring |
|
| Oral non-steroidal anti-inflammatory drug | Active Comparator | Diclofenac potassium |
|
| Placebo vaginal ring and oral pill | Placebo Comparator | Placebo vaginal ring and placebo oral pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam | Drug | 1 Meloxicam Vaginal Ring (MVR) for 4-6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percentage of primary dysmenorrhea reduction | Change in primary dysmenorrhea using the VAS (0 = pain-free, 10 = maximum pain intensity) for the vaginal ring with meloxicam used during the perimenstrual period compared with a placebo ring. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum effective dose of meloxicam | Determine the minimum effective dose of the vaginal ring with meloxicam in primary dysmenorrhea using a survey. This survey includes a VAS (0 = pain-free, 10 = maximum pain intensity) to evaluate pain intensity, questions about the pain type (superficial, deep), pain location (diffuse, localized), pain duration (for a moment, intermittent, constant), location in the abdominal or back region (yes/no), and the presence of breast pain, thigh pain, mood changes, mastalgia, gastrointestinal disorders, abdominal distension, headache, dizziness, or acne (all with yes/no responses). Furthermore, the survey includes quality of life assessments (effects on routine activity, on work activity and/or housework, social and recreational activities, family and/or interpersonal relationships, state of mind, and sleep quality: 0 = no negative effect, 10 = maximum negative effect). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grünenthal Study Director | Grünenthal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Chileno de Medicina Reproductiva (ICMER) | Santiago | 8320165 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20091521 | 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. | |
| 15050982 | 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. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Diclofenac Potassium | Drug | 1 tablet 50 mg diclofenac every 12 hours for 4-6 days |
|
| Placebo Oral | Drug | 1 placebo tablet every 12 hours for 4-6 days |
|
| Placebo Vaginal | Drug | 1 placebo vaginal ring for 4-6 days |
|
| 5 months |
| Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac | Compare the effect of a vaginal ring with meloxicam versus the oral administration of a non-steroidal anti-inflammatory drug commonly used for primary dysmenorrhea during one menstrual cycle, using a survey. This survey includes a VAS (0 = pain-free, 10 = maximum pain intensity) to evaluate pain intensity, questions about the pain type (superficial, deep), pain location (diffuse, localized), pain duration (for a moment, intermittent, constant), location in the abdominal or back region (yes/no), and the presence of breast pain, thigh pain, mood changes, mastalgia, gastrointestinal disorders, abdominal distension, headache, dizziness, or acne (all with yes/no responses). Furthermore, the survey includes quality of life assessments (effects on routine activity, on work activity and/or housework, social and recreational activities, family and/or interpersonal relationships, state of mind, and sleep quality: 0 = no negative effect, 10 = maximum negative effect). | 5 months |
| 15225193 | 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. |
| 18180635 | 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |