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临床试验/NCT02144246
NCT02144246终止1 期

Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

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

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

Other

Patients will act as their own controls. Will have no hormones for 3 months

干预措施: Non-hormonal period (Other)

Post-intervention

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Courtney Schreiber

Family Planning Director

University of Pennsylvania

研究点 (1)

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