Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Exacerbation rate
研究概览
简要总结
Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations.
We hypothesize:
1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit,
1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception,
1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and
1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception.
Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls.
We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female, reproductive age (18-40), cyclic CF exacerbations, regular menstrual cycles
排除标准
- •pregnant, desires pregnancy, contra-indication to hormonal contraception, currently using hormonal contraception
研究组 & 干预措施
Pre-intervention
Patients will act as their own controls. Will have no hormones for 3 months
干预措施: Non-hormonal period (Other)
Post-intervention
Ortho-cyclen (or a generic equivalent) which is Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
干预措施: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg (Drug)
结局指标
主要结局
Exacerbation rate
时间窗: 18 months
Pseudomonas mucoidy conversion Quality of life Pulmonary function
Satisfaction with contraception
时间窗: 18 months
Satisfaction overall measured by a visual analog scale 0-10
次要结局
- Cervical Mucus(3 months)
研究者
Courtney Schreiber
Family Planning Director
University of Pennsylvania
