Contraceptive Hormones and Women With Cystic Fibrosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception

Intervention / Treatment
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* Other: Non-hormonal period
* Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pre-intervention<br>Patients will act as their own controls. Will have no hormones for 3 months | Other: Non-hormonal period<br> <br> |
| Experimental: Post-intervention<br>Ortho-cyclen (or a generic equivalent) which is Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg | Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg<br> <br> * Other names: Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with contraception | Satisfaction overall | 18 months | 
| Exacerbation rate | Pseudomonas mucoidy conversion Quality of life Pulmonary function | 18 months | 
| Satisfaction with contraception | Satisfaction overall measured by a visual analog scale 0-10 | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Mucus | Cervical mucus of CF patients relative to healthy controls | 3 months |