Contraceptive Hormones and Women With Cystic Fibrosis

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02144246

Enrollment

Registered

2014-05-21

Start date

2014-05-31

Completion date

Unknown

Last updated

2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception

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.

Interventions

DRUGOrtho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg

OTHERNon-hormonal period

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Satisfaction with contraception	18 months	Satisfaction overall
Exacerbation rate	18 months	Pseudomonas mucoidy conversion Quality of life Pulmonary function

Secondary

Measure	Time frame	Description
Cervical Mucus	3 months	Cervical mucus of CF patients relative to healthy controls

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026