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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.
Age
18 - 40 years
Sex
FEMALE
Healthy Volunteers
No
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
May 1, 2014
Primary Completion Date
July 1, 2015
Last Updated
January 8, 2016
5
ACTUAL participants
Non-hormonal period
OTHER
Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
DRUG
Lead Sponsor
University of Pennsylvania
Collaborators
Data Source & Attribution
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