Contraceptive Hormones and Women With Cystic Fibrosis

Phase 1

Terminated

• Conditions: Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception
• Interventions: Other: Non-hormonal period; Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg

• Registration Number: NCT02144246
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-21
• Primary Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-intervention	Non-hormonal period	Patients will act as their own controls. Will have no hormones for 3 months
Post-intervention	Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg	Ortho-cyclen (or a generic equivalent) which is Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg

Primary Outcome Measures

Name	Time	Method
Satisfaction with contraception	18 months	Satisfaction overall measured by a visual analog scale 0-10
Exacerbation rate	18 months	Pseudomonas mucoidy conversion Quality of life Pulmonary function

Secondary Outcome Measures

Name	Time	Method
Cervical Mucus	3 months	Cervical mucus of CF patients relative to healthy controls

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States