Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception Clinical Trial
Official title:
Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label