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

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255045
• Other study ID #: AVM002
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 27, 2014
• Est. completion date: March 16, 2016

Study information

• Verified date: May 2019
• Source: Laboratorios Andromaco S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 16, 2016
• Est. primary completion date: February 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• Meloxicam
1 Meloxicam Vaginal Ring (MVR) for 4-6 days
• Diclofenac Potassium
1 tablet 50 mg diclofenac every 12 hours for 4-6 days
• Placebo Oral
1 placebo tablet every 12 hours for 4-6 days
• Placebo Vaginal
1 placebo vaginal ring for 4-6 days

Locations

Country	Name	City	State
Chile	Instituto Chileno de Medicina Reproductiva (ICMER)	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Andromaco S.A.

Country where clinical trial is conducted

Chile, 

References & Publications (4)

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. — View 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. — View Citation

Harel Z. Cyclooxygenase-2 specific inhibitors in the treatment of dysmenorrhea. J Pediatr Adolesc Gynecol. 2004 Apr;17(2):75-9. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD001751. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 months
Secondary	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).	5 months
Secondary	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).	5 months