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Completed

NCT Number: NCT02255045

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

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).

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Instituto Chileno de Medicina Reproductiva (ICMER)

Santiago, 8320165, Chile

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meloxicam

Drug

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

Diclofenac Potassium

Drug

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

Placebo Oral

Drug

1 placebo tablet every 12 hours for 4-6 days

Placebo Vaginal

Drug

1 placebo vaginal ring for 4-6 days

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Laboratorios Andromaco S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2014
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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