Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age
Overview
- Phase
- Phase 2
- Intervention
- Placebo Oral
- Conditions
- Dysmenorrhea
- Sponsor
- Laboratorios Andromaco S.A.
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Efficacy: Percentage of primary dysmenorrhea reduction
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
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
Arms & Interventions
Dose 1 of meloxicam in vaginal ring
2.4 g of meloxicam in a vaginal ring
Intervention: Placebo Oral
Dose 2 of meloxicam in vaginal ring
3.0 g of meloxicam in a vaginal ring
Intervention: Meloxicam
Dose 1 of meloxicam in vaginal ring
2.4 g of meloxicam in a vaginal ring
Intervention: Meloxicam
Dose 2 of meloxicam in vaginal ring
3.0 g of meloxicam in a vaginal ring
Intervention: Placebo Oral
Oral non-steroidal anti-inflammatory drug
Diclofenac potassium
Intervention: Diclofenac Potassium
Oral non-steroidal anti-inflammatory drug
Diclofenac potassium
Intervention: Placebo Vaginal
Placebo vaginal ring and oral pill
Placebo vaginal ring and placebo oral pill
Intervention: Placebo Oral
Placebo vaginal ring and oral pill
Placebo vaginal ring and placebo oral pill
Intervention: Placebo Vaginal
Outcomes
Primary Outcomes
Efficacy: Percentage of primary dysmenorrhea reduction
Time Frame: 5 months
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.
Secondary Outcomes
- Minimum effective dose of meloxicam(5 months)
- Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac(5 months)