Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2014-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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Pre-intervention
Patients will act as their own controls. Will have no hormones for 3 months
Non-hormonal period
Post-intervention
Ortho-cyclen (or a generic equivalent) which is Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
Interventions
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Non-hormonal period
Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Society of Family Planning
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Courtney Schreiber
Family Planning Director
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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819889
Identifier Type: -
Identifier Source: org_study_id
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