Pharmacokinetics of Drospirenone Only Pills in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Plasma concentration versus Time of Drospirenone
研究概览
简要总结
The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption
详细描述
After being informed about the study and potential risks, all participants giving written informed consent who meet the eligibility requirements will take Drospirenone-only pills (4 mg, once daily). Between the 21st and 28th day of Drospirenone taking, pharmacokinetics will be measured. Pre-bariatric surgery pharmacokinetics study will be compared with post-bariatric surgery pharmacokinetics study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Thai women aged 18-45 years who are obese and had an appointment for Bariatric surgery at Chulalongkorn Hospital
- •Need contraception
- •Able to use non-hormonal contraception during the study
- •Giving consent
排除标准
- •Pregnancy or history of giving birth within 3 months
- •Breastfeeding within the 6 months
- •History of using DMPA within 12 months
- •History of using other types of hormonal birth control pills within 4 weeks
- •History of bilateral oophorectomy or hysterectomy
- •Suspected ovarian tumor or pathological ovarian cyst
- •Regular cigarette smoking
- •Contraindications to Drospirenone
研究组 & 干预措施
Drospirenone
Participants received Drospirenone 4 mg tablet orally once daily for 21-28 days
干预措施: Drospirenone (Drug)
结局指标
主要结局
Plasma concentration versus Time of Drospirenone
时间窗: 1 month before and 1 month after bariatric surgery
Plasma concentration of Drospirenone will be measured at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8 hours post-dose
次要结局
- Number of Participants With Treatment-Related Adverse Events(1 month)