Contraceptive Hormones and Women With Cystic Fibrosis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Society of Family Planning
• Treatments: Contraceptive Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Fluoroquinolones; Hormones; Moxifloxacin; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Norgestrel; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• female, reproductive age (18-40), cyclic CF exacerbations, regular menstrual cycles

Exclusion Criteria:

• pregnant, desires pregnancy, contra-indication to hormonal contraception, currently using hormonal contraception