Background: Women with cystic fibrosis (CF) now have a median age of survival of 38.3 years, and for the first time in history, may require contraception on a population-based level. Additionally, it appears that female CF patients are prone to a more severe disease course than their male counterparts. This CF “gender gap” may be mediated by endogenous estradiol. Limited data suggest that women using combined hormonal contraception suffer fewer exacerbations. We hypothesize that combined hormonal contraception is acceptable to women with CF and that there are disease-specific, non-contraceptive benefits for women with CF.
Objectives: To gather preliminary data on the acceptability of hormonal contraception in women with CF and to preliminarily evaluate the physiologic effects of combined hormonal contraception on CF disease.
Methods: We propose a time-series prospective pilot trial in which 20 female CF patients with regular menstrual cycles and cyclic exacerbations will be recruited to undergo evaluation with and without a single formulation of combined oral contraception (COC). During an initial 3-cycle hormone-free interval, participants will complete twice monthly pulmonary function tests (PFTs), quality of life assessments and provide sputum samples (assessed for the presence of Pseudomonas and pathologic mucoidy conversion). After this period, participants will initiate COCs and will be followed for 6 additional months. In this phase, participants will complete monthly PFTs, quality of life assessments, and provide sputum samples and estradiol levels. Using these methods, lung function and Pseudomonas mucoidy conversion will be correlated with hormone levels. Satisfaction of COC will be assessed at the end of the study period using a 10-point Likert scale.
Expected Results: We hypothesize that COCs will be acceptable to women with CF and that COCs will improve validated clinical parameters of CF.