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

Laboratorios Andromaco S.A.68 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dysmenorrhea

Interventions

MeloxicamDRUG

1 Meloxicam Vaginal Ring (MVR) for 4-6 days

Diclofenac PotassiumDRUG

1 tablet 50 mg diclofenac every 12 hours for 4-6 days

Placebo OralDRUG

1 placebo tablet every 12 hours for 4-6 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Instituto Chileno de Medicina Reproductiva (ICMER)

Santiago, Chile

Outcomes

Primary Outcomes

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.

Time frame: 5 months

Secondary Outcomes

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).

Time frame: 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).

Data from ClinicalTrials.gov

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