Dysmenorrhea
Conditions
Brief 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).
Interventions
DRUGMeloxicam
1 Meloxicam Vaginal Ring (MVR) for 4-6 days
1 tablet 50 mg diclofenac every 12 hours for 4-6 days
DRUGPlacebo Oral
1 placebo tablet every 12 hours for 4-6 days
DRUGPlacebo Vaginal
1 placebo vaginal ring for 4-6 days
Sponsors
Laboratorios Andromaco S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Percentage of primary dysmenorrhea reduction | 5 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum effective dose of meloxicam | 5 months | 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). |
| Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac | 5 months | 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). |
Countries
Chile
Outcome results
None listed