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

NCT02255045 | Completed Phase 2

• 1 other identifier: AVM002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Minimum effective dose of meloxicam

  5 months

• Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac

  5 months

Study Arms (4)

Dose 1 of meloxicam in vaginal ring

EXPERIMENTAL

2.4 g of meloxicam in a vaginal ring

Drug: Meloxicam; Drug: Placebo Oral

Dose 2 of meloxicam in vaginal ring

EXPERIMENTAL

3.0 g of meloxicam in a vaginal ring

Drug: Meloxicam; Drug: Placebo Oral

Oral non-steroidal anti-inflammatory drug

ACTIVE COMPARATOR

Diclofenac potassium

Drug: Diclofenac Potassium; Drug: Placebo Vaginal

Placebo vaginal ring and oral pill

PLACEBO COMPARATOR

Placebo vaginal ring and placebo oral pill

Drug: Placebo Oral; Drug: Placebo Vaginal

Interventions

Meloxicam DRUG

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

Dose 1 of meloxicam in vaginal ring; Dose 2 of meloxicam in vaginal ring

Diclofenac Potassium DRUG

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

Oral non-steroidal anti-inflammatory drug

Placebo Oral DRUG

1 placebo tablet every 12 hours for 4-6 days

Dose 1 of meloxicam in vaginal ring; Dose 2 of meloxicam in vaginal ring; Placebo vaginal ring and oral pill

Placebo Vaginal DRUG

1 placebo vaginal ring for 4-6 days

Oral non-steroidal anti-inflammatory drug; Placebo vaginal ring and oral pill

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Andromaco S.A.: lead

Study Sites (1)

Instituto Chileno de Medicina Reproductiva (ICMER)

Santiago, 8320165, Chile

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Meloxicam; Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Grünenthal Study Director

  Grünenthal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: October 2, 2014
• Study Start: June 27, 2014
• Primary Completion: February 21, 2016
• Study Completion: March 16, 2016
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)