Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Efficacy: Percentage of primary dysmenorrhea reduction
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dose 1 of meloxicam in vaginal ring
2.4 g of meloxicam in a vaginal ring
干预措施: Placebo Oral (Drug)
Dose 2 of meloxicam in vaginal ring
3.0 g of meloxicam in a vaginal ring
干预措施: Meloxicam (Drug)
Dose 1 of meloxicam in vaginal ring
2.4 g of meloxicam in a vaginal ring
干预措施: Meloxicam (Drug)
Dose 2 of meloxicam in vaginal ring
3.0 g of meloxicam in a vaginal ring
干预措施: Placebo Oral (Drug)
Oral non-steroidal anti-inflammatory drug
Diclofenac potassium
干预措施: Diclofenac Potassium (Drug)
Oral non-steroidal anti-inflammatory drug
Diclofenac potassium
干预措施: Placebo Vaginal (Drug)
Placebo vaginal ring and oral pill
Placebo vaginal ring and placebo oral pill
干预措施: Placebo Oral (Drug)
Placebo vaginal ring and oral pill
Placebo vaginal ring and placebo oral pill
干预措施: Placebo Vaginal (Drug)
结局指标
主要结局
Efficacy: Percentage of primary dysmenorrhea reduction
时间窗: 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.
次要结局
- Minimum effective dose of meloxicam(5 months)
- Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac(5 months)