Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea
- Conditions
- Dysmenorrhea
- Interventions
- Registration Number
- NCT02255045
- Lead Sponsor
- Laboratorios Andromaco S.A.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 68
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo vaginal ring and oral pill Placebo Oral Placebo vaginal ring and placebo oral pill Oral non-steroidal anti-inflammatory drug Placebo Vaginal Diclofenac potassium Dose 2 of meloxicam in vaginal ring Placebo Oral 3.0 g of meloxicam in a vaginal ring Placebo vaginal ring and oral pill Placebo Vaginal Placebo vaginal ring and placebo oral pill Dose 1 of meloxicam in vaginal ring Meloxicam 2.4 g of meloxicam in a vaginal ring Dose 1 of meloxicam in vaginal ring Placebo Oral 2.4 g of meloxicam in a vaginal ring Dose 2 of meloxicam in vaginal ring Meloxicam 3.0 g of meloxicam in a vaginal ring Oral non-steroidal anti-inflammatory drug Diclofenac Potassium Diclofenac potassium
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Instituto Chileno de Medicina Reproductiva (ICMER)
🇨🇱Santiago, Chile