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

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

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 Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: Meloxicam; Drug: Placebo Oral; Drug: Diclofenac Potassium; Drug: Placebo Vaginal

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile, 8320165
    • Instituto Chileno De Medicina Reproductiva (ICMER)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratorios Andromaco S.A.

Publications and helpful links

General Publications

• Marjoribanks J, Proctor M, Farquhar C, Derks RS. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001751. doi: 10.1002/14651858.CD001751.pub2.
• Harel Z. Cyclooxygenase-2 specific inhibitors in the treatment of dysmenorrhea. J Pediatr Adolesc Gynecol. 2004 Apr;17(2):75-9. doi: 10.1016/j.jpag.2004.01.002.
• de Mello NR, Baracat EC, Tomaz G, Bedone AJ, Camargos A, Barbosa IC, de Souza RN, Rumi DO, Martinez Alcala FO, Velasco JA, Cortes RJ. Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea. Acta Obstet Gynecol Scand. 2004 Jul;83(7):667-73. doi: 10.1111/j.0001-6349.2004.00433.x.
• Chantler I, Mitchell D, Fuller A. The effect of three cyclo-oxygenase inhibitors on intensity of primary dysmenorrheic pain. Clin J Pain. 2008 Jan;24(1):39-44. doi: 10.1097/AJP.0b013e318156dafc.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2014
• Primary Completion (Actual): February 21, 2016
• Study Completion (Actual): March 16, 2016

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: September 29, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Diclofenac; Meloxicam
• Other Study ID Numbers: AVM002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No