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Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis (CASE4CF)

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ClinicalTrials.gov Identifier: NCT04568980
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Emily Godfrey, University of Washington

Brief 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.

Condition or disease
Cystic Fibrosis Contraception

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 625 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis: A Retrospective Analysis
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Hormonal contraceptive users
Persons exposed to any hormonal method of birth control. This includes combined oral contraceptive pills, combined transdermal patch, combined vaginal ring, progestin-only pills, depo-medroxyacetate, levonorgestrel intrauterine system/device, hormonal subdermal implant
Non-hormonal contraceptive users
Persons exposed to any non-hormonal method of birth control. This includes male or female sterilization methods, Copper intrauterine device, internal/external condoms, diaphragm, cervical cap, withdrawal, sponge, fertility based methods, spermicide
Non-contraceptive users
Persons who did not use any method of birth control



Primary Outcome Measures :
  1. Pulmonary exacerbations [ Time Frame: 2010-2018 ]
    Annual pulmonary exacerbation rate (PEx) (defined as episodes requiring intravenous antibiotic use at home or in hospital)


Secondary Outcome Measures :
  1. Lung function [ Time Frame: 2010-2018 ]
    Absolute change in FEV1 (in liters) measurements over time.

  2. Thromboembolism [ Time Frame: 2010-2018 ]
    Incidence of venous or arterial thromboembolism. Noted on self-respondent survey (defined as blood clot requiring anticoagulation treatment)

  3. Liver dysfunction [ Time Frame: 2010-2018 ]
    Incidence of gallstones requiring surgery, hepatic steatosis, hepatic cirrhosis and/or increased liver enzyme test values (ALT/GGT)

  4. Serum glucose trends [ Time Frame: 2010-2018 ]
    Incidence of insulin resistance or time to CF-related diabetes requiring insulin treatment

  5. Nutritional status [ Time Frame: 2010-2018 ]
    BMI trends

  6. Bone health [ Time Frame: 2013-2018 ]
    DXA scan determination of osteopenia or osteoporosis

  7. Unintended pregnancy [ Time Frame: 2010-2018 ]
    Absolute number of self-reported unplanned pregnancies. We will also correlate date of reported unplanned pregnancy with dates of taking a CFTR modulator

  8. Pseudomonas aeruginosa [ Time Frame: 2010-2018 ]
    Rate of conversion from non-mucoid to mucoid P. aeruginosa



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with cystic fibrosis who have not used any form of contraception, or who have used contraception for protection against pregnancy or for treatment of dysmenorrhea, pelvic pain, abnormally heavy or prolonged menstrual bleeding, endometriosis, acne or amenorrhea.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568980


Contacts
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Contact: Molly Ruben, MPH 206-685-3276 mruben@uw.edu
Contact: Emily M Godfrey, MD 206-685-4895 godfreye@uw.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Sigrid Ladores, PhD       sladores@uab.edu   
United States, California
University of California - San Diego Not yet recruiting
San Diego, California, United States, 92093
Contact: Sheila Mody, MD       smody@ucsd.edu   
Contact: Douglas Conrad, MD       dconrad@ucsd.edu   
United States, Colorado
National Jewish Health Not yet recruiting
Denver, Colorado, United States, 80206
Contact: Jennifer Taylor-Cousar, MD       TaylorCousarJ@njhealth.org   
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21218
Contact: Natalie West, MD       nwest5@jhmi.edu   
United States, Massachusetts
Boston Children's Hospital/Harvard Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Ahmet Uluer, MD       Ahmet.Uluer@childrens.harvard.edu   
United States, New York
Mount Sinai Beth Israel Not yet recruiting
New York, New York, United States, 10003
Contact: Patricia Walker, MD       Patricia.Walker@mountsinai.org   
Contact: Elinor Schwind, MS       Elinor.Schwind@mountsinai.org   
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Andrea Roe, MD       Andrea.Roe@uphs.upenn.edu   
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Traci Kazmerski, MD       Traci.Kazmerski@chp.edu   
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Raksha Jain, MD       raksha.jain@utsouthwestern.edu   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Moira L Aitken, MD    206-543-3166    moira@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Emily M Godfrey, MD University of Washington
  Study Documents (Full-Text)

Documents provided by Emily Godfrey, University of Washington:
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Responsible Party: Emily Godfrey, Associate Professor, School of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT04568980    
Other Study ID Numbers: STUDY00008095
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emily Godfrey, University of Washington:
birth control
contraception
cystic fibrosis
bone mineral density
CFTR modulator
women
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases