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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255045
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: Meloxicam Drug: Diclofenac Potassium Drug: Placebo Oral Drug: Placebo Vaginal Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age
Actual Study Start Date : June 27, 2014
Actual Primary Completion Date : February 21, 2016
Actual Study Completion Date : March 16, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
Drug Information available for: Meloxicam

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




Primary Outcome Measures :
  1. Efficacy: Percentage of primary dysmenorrhea reduction [ Time Frame: 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 :
  1. Minimum effective dose of meloxicam [ Time Frame: 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).

  2. Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255045


Locations
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Chile
Instituto Chileno de Medicina Reproductiva (ICMER)
Santiago, Chile, 8320165
Sponsors and Collaborators
Laboratorios Andromaco S.A.
Investigators
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Study Director: Grünenthal Study Director Grünenthal GmbH
Publications:
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Responsible Party: Laboratorios Andromaco S.A.
ClinicalTrials.gov Identifier: NCT02255045    
Other Study ID Numbers: AVM002
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Diclofenac
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors