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Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis

NCT04568980 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 562

Last updated 2023-05-22

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Emily M Godfrey, MD, MPH · University of Washington

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2022-05-02
Completion
2022-12-06

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04568980 on ClinicalTrials.gov