Phase 1 Study of Assessment of Local Absorption of a Non-steroidal Antiinflammatory Drug (NSAID), Inhibitor of Cyclooxygenase 2 (COX-2) Meloxicam, Through a Vaginal Ring and Its Effect on Ovarian Cycle in Fertile Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of participants with follicular rupture delay
研究概览
简要总结
In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a local route (vaginal) and to observe the effect on follicular development.
详细描述
Each volunteer will participate for 3 menstrual cycles, beginning with one menstrual control cycle without treatment, following by one menstrual cycle with meloxicam ring administration, and finishing with another control menstrual cycle.
Meloxicam will be administered in the second menstrual cycle via a vaginal ring in two doses of 2.4 g or 3.0 g/ring. The safety of the vaginal ring and the absorption of meloxicam will be assessed. Also the effect on follicular development and if it maintains ovarian cyclicity, as shown in a recent study with oral administration, will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Previous (or history of) proven fertility
- •Regular menstrual cycle
- •Surgically sterile
- •Without breastfeeding
- •Haemoglobin at least 11g/dL
- •Willing to participate in the study
排除标准
- •Allergy to meloxicam or other NSAID
- •Allergy to silicone polymer
- •Vaginal discharge non diagnosticated
- •History of shock toxic syndrome
- •History of : gastrointestinal, bleeding, renal, liver, heart, brain,clot, endocrine or pulmonary disorders
研究组 & 干预措施
2.4 g Meloxicam Vaginal Ring
Continuous wearing during one menstrual cycle (6 participants)
干预措施: Meloxicam 2.4 g (Drug)
3.0 g Meloxicam Vaginal Ring
Continuous wearing during one menstrual cycle (6 participants)
干预措施: Meloxicam 3.0 g (Drug)
结局指标
主要结局
Number of participants with follicular rupture delay
时间窗: Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days
Evaluate effective dose of maximum local safety that causes a greater proportion of follicular rupture delays when it is administered continuously, starting on the day 5 +/- 1 of the cycle until next menses.
次要结局
- Bleeding patterns with meloxicam vaginal ring(one menstrual cycle)
- Pharmacokinetic of meloxicam via vaginal route: Tmax(An expected average of 28 days)
- Pharmacokinetic of meloxicam via vaginal route: AUC(An expected average of 28 days)
- Pharmacokinetic of meloxicam via vaginal route: Cmax(An expected average of 28 days)