Clinical trial NCT02255045: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Laboratorios Andromaco S.A.
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Efficacy: Percentage of primary dysmenorrhea reduction
timeFrame: 5 months
Secondary outcomes:
measure: Minimum effective dose of meloxicam
timeFrame: 5 months
measure: Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac
timeFrame: 5 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Instituto Chileno de Medicina Reproductiva (ICMER)
Study officials:
affiliation: Grünenthal GmbH
name: Grünenthal Study Director
role: STUDY_DIRECTOR
References:
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: 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: 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: 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.