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

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Meloxicam
Diclofenac Potassium
Placebo Oral
Placebo Vaginal
Sponsored by
Laboratorios Andromaco S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Chileno de Medicina Reproductiva (ICMER)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dose 1 of meloxicam in vaginal ring

Dose 2 of meloxicam in vaginal ring

Oral non-steroidal anti-inflammatory drug

Placebo vaginal ring and oral pill

Arm Description

2.4 g of meloxicam in a vaginal ring

3.0 g of meloxicam in a vaginal ring

Diclofenac potassium

Placebo vaginal ring and placebo oral pill

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
September 22, 2014
Last Updated
May 2, 2019
Sponsor
Laboratorios Andromaco S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02255045
Brief Title
Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea
Official Title
Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 27, 2014 (Actual)
Primary Completion Date
February 21, 2016 (Actual)
Study Completion Date
March 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Andromaco S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1 of meloxicam in vaginal ring
Arm Type
Experimental
Arm Description
2.4 g of meloxicam in a vaginal ring
Arm Title
Dose 2 of meloxicam in vaginal ring
Arm Type
Experimental
Arm Description
3.0 g of meloxicam in a vaginal ring
Arm Title
Oral non-steroidal anti-inflammatory drug
Arm Type
Active Comparator
Arm Description
Diclofenac potassium
Arm Title
Placebo vaginal ring and oral pill
Arm Type
Placebo Comparator
Arm Description
Placebo vaginal ring and placebo oral pill
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Intervention Description
1 Meloxicam Vaginal Ring (MVR) for 4-6 days
Intervention Type
Drug
Intervention Name(s)
Diclofenac Potassium
Intervention Description
1 tablet 50 mg diclofenac every 12 hours for 4-6 days
Intervention Type
Drug
Intervention Name(s)
Placebo Oral
Intervention Description
1 placebo tablet every 12 hours for 4-6 days
Intervention Type
Drug
Intervention Name(s)
Placebo Vaginal
Intervention Description
1 placebo vaginal ring for 4-6 days
Primary Outcome Measure Information:
Title
Efficacy: Percentage of primary dysmenorrhea reduction
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Minimum effective dose of meloxicam
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).
Time Frame
5 months
Title
Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac
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).
Time Frame
5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grünenthal Study Director
Organizational Affiliation
Grünenthal GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Chileno de Medicina Reproductiva (ICMER)
City
Santiago
ZIP/Postal Code
8320165
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20091521
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.
Results Reference
background
PubMed Identifier
15050982
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.
Results Reference
background
PubMed Identifier
15225193
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.
Results Reference
background
PubMed Identifier
18180635
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.
Results Reference
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Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea

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