<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255045</url>
  </required_header>
  <id_info>
    <org_study_id>AVM002</org_study_id>
    <nct_id>NCT02255045</nct_id>
  </id_info>
  <brief_title>Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea</brief_title>
  <official_title>Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratorios Andromaco S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratorios Andromaco S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose that the sustained administration of a vaginal ring would have a&#xD;
      better response with respect to pain and a better safety profile than the oral administration&#xD;
      of a non-steroidal anti-inflammatory drug.&#xD;
&#xD;
      To assess the relief of the symptoms associated with dysmenorrhea, a specific survey was&#xD;
      elaborated that also includes a Visual Analog Scale (VAS) to objectify and measure&#xD;
      dysmenorrhea as is the case with McGill's Pain Questionnaire (MPQ).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2014</start_date>
  <completion_date type="Actual">March 16, 2016</completion_date>
  <primary_completion_date type="Actual">February 21, 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: Percentage of primary dysmenorrhea reduction</measure>
    <time_frame>5 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimum effective dose of meloxicam</measure>
    <time_frame>5 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac</measure>
    <time_frame>5 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>Dose 1 of meloxicam in vaginal ring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2.4 g of meloxicam in a vaginal ring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 2 of meloxicam in vaginal ring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3.0 g of meloxicam in a vaginal ring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral non-steroidal anti-inflammatory drug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diclofenac potassium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo vaginal ring and oral pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo vaginal ring and placebo oral pill</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meloxicam</intervention_name>
    <description>1 Meloxicam Vaginal Ring (MVR) for 4-6 days</description>
    <arm_group_label>Dose 1 of meloxicam in vaginal ring</arm_group_label>
    <arm_group_label>Dose 2 of meloxicam in vaginal ring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Potassium</intervention_name>
    <description>1 tablet 50 mg diclofenac every 12 hours for 4-6 days</description>
    <arm_group_label>Oral non-steroidal anti-inflammatory drug</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral</intervention_name>
    <description>1 placebo tablet every 12 hours for 4-6 days</description>
    <arm_group_label>Dose 1 of meloxicam in vaginal ring</arm_group_label>
    <arm_group_label>Dose 2 of meloxicam in vaginal ring</arm_group_label>
    <arm_group_label>Placebo vaginal ring and oral pill</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Vaginal</intervention_name>
    <description>1 placebo vaginal ring for 4-6 days</description>
    <arm_group_label>Oral non-steroidal anti-inflammatory drug</arm_group_label>
    <arm_group_label>Placebo vaginal ring and oral pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Regular menstrual cycles on previous 3 months (24-35 days),&#xD;
&#xD;
          -  Primary dysmenorrhea on 3 previous months,&#xD;
&#xD;
          -  With tubal ligation or users of condom for contraception,&#xD;
&#xD;
          -  Hemoglobin of at least 11 g/dl,&#xD;
&#xD;
          -  Safety blood analysis in normal levels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary dysmenorrhea,&#xD;
&#xD;
          -  Users of hormonal contraceptives (2 months prior to the study) or intrauterine devices&#xD;
             (IUDs) (1 month prior the study).&#xD;
&#xD;
          -  Allergy to any anti-inflammatory drug including meloxicam or diclofenac.&#xD;
&#xD;
          -  Allergy to silicon.&#xD;
&#xD;
          -  Pregnant or in lactation.&#xD;
&#xD;
          -  Women with untreated or decompensated endocrine disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grünenthal Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Grünenthal GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Chileno de Medicina Reproductiva (ICMER)</name>
      <address>
        <city>Santiago</city>
        <zip>8320165</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20091521</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15050982</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15225193</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18180635</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Meloxicam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255045
org study id: AVM002
nct id: NCT02255045
lead sponsor: 
has dmc: No
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).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Efficacy: Percentage of primary dysmenorrhea reduction
time frame: 5 months
description: 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.
measure: Minimum effective dose of meloxicam
time frame: 5 months
description: 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).
measure: Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac
time frame: 5 months
description: 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).
arm group label: Dose 1 of meloxicam in vaginal ring
arm group type: Experimental
description: 2.4 g of meloxicam in a vaginal ring
arm group label: Dose 2 of meloxicam in vaginal ring
arm group type: Experimental
description: 3.0 g of meloxicam in a vaginal ring
arm group label: Oral non-steroidal anti-inflammatory drug
arm group type: Active Comparator
description: Diclofenac potassium
arm group label: Placebo vaginal ring and oral pill
arm group type: Placebo Comparator
description: Placebo vaginal ring and placebo oral pill
intervention type: Drug
intervention name: Meloxicam
description: 1 Meloxicam Vaginal Ring (MVR) for 4-6 days
arm group label: Dose 1 of meloxicam in vaginal ring
arm group label: Dose 2 of meloxicam in vaginal ring
intervention type: Drug
intervention name: Diclofenac Potassium
description: 1 tablet 50 mg diclofenac every 12 hours for 4-6 days
arm group label: Oral non-steroidal anti-inflammatory drug
intervention type: Drug
intervention name: Placebo Oral
description: 1 placebo tablet every 12 hours for 4-6 days
arm group label: Dose 1 of meloxicam in vaginal ring
arm group label: Dose 2 of meloxicam in vaginal ring
arm group label: Placebo vaginal ring and oral pill
intervention type: Drug
intervention name: Placebo Vaginal
description: 1 placebo vaginal ring for 4-6 days
arm group label: Oral non-steroidal anti-inflammatory drug
arm group label: Placebo vaginal ring and oral pill
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Grünenthal Study Director
role: Study Director
affiliation: Grünenthal GmbH
facility: 
country: Chile
citation: 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.
PMID: 20091521
citation: 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.
PMID: 15050982
citation: 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.
PMID: 15225193
citation: 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.
PMID: 18180635
responsible party type: Sponsor
mesh term: Dysmenorrhea
mesh term: Diclofenac
mesh term: Meloxicam
sharing ipd: No