Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— CASE4CF  

Official title:

Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis: A Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568980
• Other study ID #: STUDY00008095
• Status: Completed
• Start date: September 30, 2020
• Est. completion date: December 6, 2022

Study information

• Verified date: May 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a non-randomized, non-interventional, observational cohort design among reproductive-aged women (ages 18-45 years) with CF. The investigators intend to ask about 625 female participants to provide information about their types of past contraceptive use from 2008 through the most recent data available from CFFPR (2018 or 2019). Before initiating our trial among up to 625 respondents, the investigators intend to pre-test the survey questions on our self-respondent questionnaire among as many as 50 women with and without CF through CFF Community Voice, the Cystic Fibrosis Research, Inc. (CFRI), and the Cystic Fibrosis Reproductive and Sexual Health Collaborative (CFReSHC). Pre-testing the study survey questions will help ensure contraceptive, pregnancy, and other reproductive health data from respondents for the larger phase of this study are as complete and accurate as possible. Once the survey has been piloted and revised accordingly, the investigators will collect past contraceptive, pregnancy and other reproductive health data from up to 625 women at 10 different CF centers. The investigators may over-sample by 25 participants because it is possible that some participants from UW, UTSW and National Jewish may have participated an earlier published study related to contraceptive use and CFFPR. Recruiting through the CF centers will help ensure that women with a confirmed diagnosis of CF respond to the finalized survey. The investigators will link respondent self-reported contraceptive and reproductive health data with CFFPR clinical data. The investigators will ask for EMR data from the 10 different CF centers to validate DXA scan results with findings regarding osteoporosis, osteopenia, and bone fracture in the CFFPR. The investigators plan to randomly select about 10 consented subjects from each of the centers for the EMR DXA scan chart review. Because of the need to link questionnaires and clinical case report forms correctly to the same women with CF in the CFFPR clinical data, this study requests identifiable information, including the CFFPR member ID number.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: December 6, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Children's Hospital/Harvard	Boston	Massachusetts
United States	University of Texas Southwestern	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
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 California - San Diego	San Diego	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary exacerbations	Annual pulmonary exacerbation rate (PEx) (defined as episodes requiring intravenous antibiotic use at home or in hospital)	2010-2018
Secondary	Lung function	Absolute change in FEV1 (in liters) measurements over time.	2010-2018
Secondary	Thromboembolism	Incidence of venous or arterial thromboembolism. Noted on self-respondent survey (defined as blood clot requiring anticoagulation treatment)	2010-2018
Secondary	Liver dysfunction	Incidence of gallstones requiring surgery, hepatic steatosis, hepatic cirrhosis and/or increased liver enzyme test values (ALT/GGT)	2010-2018
Secondary	Serum glucose trends	Incidence of insulin resistance or time to CF-related diabetes requiring insulin treatment	2010-2018
Secondary	Nutritional status	BMI trends	2010-2018
Secondary	Bone health	DXA scan determination of osteopenia or osteoporosis	2013-2018
Secondary	Unintended pregnancy	Absolute number of self-reported unplanned pregnancies. We will also correlate date of reported unplanned pregnancy with dates of taking a CFTR modulator	2010-2018
Secondary	Pseudomonas aeruginosa	Rate of conversion from non-mucoid to mucoid P. aeruginosa	2010-2018