Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis

Completed

Conditions studied: Cystic Fibrosis, Contraception

In brief

The long-term goal is to study the safety and effectiveness of hormonal contraception for women with cystic fibrosis (CF) and contribute to national guidelines that the Cystic Fibrosis Foundation and the Centers for Disease Control and Prevention (CDC) provide to clinicians. The study objectives are to determine whether hormonal contraceptive methods improve overall pulmonary health, worsen CF-related disease or CF liver disease, or are effective against unwanted pregnancy with concomitant CF transmembrane conductance regulator (CFTR) modulator use. The hypothesis is that hormonal contraceptive methods are safe and do not worsen CF-related complications over time,improve FEV-1 when compared to non-hormonal users, and oral birth control methods with CFTR modulator use.

Key facts

Study ID

NCT04568980

Run by

University of Washington

People needed

562

Starts

2020-09-30

Expected to finish

2022-12-06

Last updated by the study team

2023-05-22

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women with cystic fibrosis age 18-45 years
• Enrolled as a participant of the Cystic Fibrosis Foundation Patient Registry
• Working email address
• Can read written English

You may not qualify if…

• History of organ transplant
• Does not have a phone number or email address in their record
• <18 years or >45 years at enrollment

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California - San Diego — San Diego, California, United States
• National Jewish Health — Denver, Colorado, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Children's Hospital/Harvard — Boston, Massachusetts, United States
• Mount Sinai Beth Israel — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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