Dysmenorrhea
Conditions
Brief summary
To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea
Interventions
DRUGMeloxicam 7.5 mg
DRUGMeloxicam 15 mg
DRUGPlacebo matching 7.5 mg meloxicam
DRUGPlacebo matching 15 mg meloxicam
DRUGPlacebo matching 500 mg mefenamic acid
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Female patients between 18 to 40 years * Patients experiencing primary (functional) dysmenorrhea during the last 3 consecutive menstrual periods. Diagnosis will be based on symptoms and clinical signs: abdominopelvic pain, may radiate to the back and along the thighs; systemic symptoms including nausea, vomit, diarrhoea, headache, fatigue, nervousness, dizziness; the symptomatology should be usually some hours to one day before commencement of visible vaginal bleeding * Evaluation of lumbar and/or abdominopelvic pain due to dysmenorrhea \> 35 mm through a 100 mm visual analogue scale (VAS) * Outpatients * Patients granting their written informed consent * Therapy with a NSAID (nonsteroidal antiinflammatory drug) is required or recommended
Exclusion criteria
* Known or suspected hypersensitivity to trial drugs or their excipients, analgesics, antipyretics or NASIDs * Analgesic concomitant treatment (between each cycle paracetamol administration will be allowed) * To initiate hormonal contraception or intrauterine devices after inclusion to this trial or during the last 3 months * Abdominal surgery or pelvic procedure scheduled during the study * Patients with organic dysmenorrhea (endometriosis, salpingitis, adnexitis, uterine retroversion, tubal cysts, ovarian cysts, pathological vaginal secretion, painful pelvic exploration, etc.) * Patients with neoplastic disorders * History of recent abdominal or pelvic trauma requiring surgery * Peptic ulcer within the past 6 months * Pregnancy or breast feeding * Asthma, nasal polyps, angioneurotic edema or rash following aspirin or NSAIDs administration * Concomitant treatment with anti-coagulants, including heparin and aspirin, lithium or methotrexate * Concomitant administration of other NSAIDs (including aspirin \> 150 mg daily) or analgesics * Confinement to bed rest * Administration of any NSAID during two days (three for oxicams) before the first administration of the trial drug * Present treatment or treatment within the last two months with corticosteroids * Impaired renal function (serum urea \> 125 % of the upper limit of normal range; serum creatinine \> 150 % of the upper limit of normal range) * Sever liver injury (alanine amino transferase ALAT \> 2 x the upper normal range limit or aspartate amino transferase ASAT \> 2 x the upper normal range limit) * Hematological disorder (platelet count \< 100,000/mm\*\*3, leucocyte count \< 3,000/mm\*\*3) * Participation in another clinical trial during this study or the previous month * Previous participation in this trial * Patient unable to comply with protocol * Bleeding disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS) | Baseline and day 3-5 of each treatment cycle |
Secondary
| Measure | Time frame |
|---|---|
| Final global assessment of efficacy by investigator on a 4-point scale | day 3-5 of the second treatment cycle |
| Final global assessment of tolerability by patient on a 4-point scale | day 3-5 of the second treatment cycle |
| Final global assessment of tolerability by investigator on a 4-point scale | day 3-5 of the second treatment cycle |
| Number of Participants with Adverse Events (AE) | Up to 4 weeks after last treatment cycle |
| Incidence of significant laboratory events | Up to 4 weeks after last treatment cycle |
| Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract | Up to 4 weeks after last treatment cycle |
| Number of gastro-intestinal adverse events (GI-AEs) | Up to 4 weeks after last treatment cycle |
| Final global assessment of efficacy by patient on a 4-point scale | day 3-5 of the second treatment cycle |
| Number of additional visits at physician due to GI-AEs | Up to 4 weeks after last treatment cycle |
| Duration of hospitalization due to drug related AEs | Up to 4 weeks after last treatment cycle |
| Number of withdrawals due to AEs | Up to 4 weeks after last treatment cycle |
| Intensity of AEs on a 3-point scale | Up to 4 weeks after last treatment cycle |
| Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS | Baseline and day 3-5 of each treatment cycle |
| Change in severity of symptomatology associated with dysmenorrhea | Baseline and day 3-5 of each treatment cycle |
| Duration of hospitalization stay due to GI-AEs | Up to 4 weeks after last treatment cycle |
Outcome results
None listed