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

Study Overview
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Brief Summary
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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).

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

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Drug: Meloxicam
* Drug: Diclofenac Potassium
* Drug: Placebo Oral
* Drug: Placebo Vaginal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Regular menstrual cycles on previous 3 months (24-35 days), 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: Secondary dysmenorrhea, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 of meloxicam in vaginal ring<br>2.4 g of meloxicam in a vaginal ring | Drug: Meloxicam<br>* 1 Meloxicam Vaginal Ring (MVR) for 4-6 days<br>Drug: Placebo Oral<br>* 1 placebo tablet every 12 hours for 4-6 days<br>|
| Experimental: Dose 2 of meloxicam in vaginal ring<br>3.0 g of meloxicam in a vaginal ring | Drug: Meloxicam<br>* 1 Meloxicam Vaginal Ring (MVR) for 4-6 days<br>Drug: Placebo Oral<br>* 1 placebo tablet every 12 hours for 4-6 days<br>|
| Active Comparator: Oral non-steroidal anti-inflammatory drug<br>Diclofenac potassium | Drug: Diclofenac Potassium<br>* 1 tablet 50 mg diclofenac every 12 hours for 4-6 days<br>Drug: Placebo Vaginal<br>* 1 placebo vaginal ring for 4-6 days<br>|
| Placebo Comparator: Placebo vaginal ring and oral pill<br>Placebo vaginal ring and placebo oral pill | Drug: Placebo Oral<br>* 1 placebo tablet every 12 hours for 4-6 days<br>Drug: Placebo Vaginal<br>* 1 placebo vaginal ring for 4-6 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 |