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

• Status: Completed
• Trial end date: 2016-03-16
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Andromaco S.A.
• Treatments: Diclofenac; Meloxicam

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