Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis

ID#: NCT04568980

Age: 18 - 45 years

Gender: Female

Healthy Subjects: Accepts Healthy Volunteers

Recruitment Status: Recruiting

Start Date: September 30, 2020

End Date: July 31, 2022

Contact Information:
Malaika R Schwartz, MPH
Emily M Godfrey, MD

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- History of organ transplant

- Does not have a phone number or email address in their record

- <18 years or >45 years at enrollment