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

Laboratorios Andromaco

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dysmenorrhea

Treatments: Drug: Placebo Oral; Drug: Diclofenac Potassium; Drug: Meloxicam; Drug: Placebo Vaginal

Study type: Interventional

Funder types: Industry

Identifiers

NCT02255045

AVM002

Details and patient eligibility

About

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).

Enrollment: 68 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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68 participants in 4 patient groups, including a placebo group

Dose 1 of meloxicam in vaginal ring

Experimental group

Description:

2.4 g of meloxicam in a vaginal ring

Treatment:

Drug: Placebo Oral

Drug: Meloxicam

Dose 2 of meloxicam in vaginal ring

Experimental group

Description:

3.0 g of meloxicam in a vaginal ring

Treatment:

Drug: Placebo Oral

Drug: Meloxicam

Oral non-steroidal anti-inflammatory drug

Active Comparator group

Description:

Diclofenac potassium

Treatment:

Drug: Diclofenac Potassium

Drug: Placebo Vaginal

Placebo vaginal ring and oral pill

Placebo Comparator group

Description:

Placebo vaginal ring and placebo oral pill

Treatment:

Drug: Placebo Oral

Drug: Placebo Vaginal