Cystic FibrosisCASE4CFNCT04568980
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
An observational study of Cystic Fibrosis and Contraception, run by University of Washington at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Contraception
- Type of treatment
- Pill or oral medicine
- How many people
- 562 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Sep 2020to 6 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- History of organ transplant
- Does not have a phone number or email address in their record
- <18 years or >45 years at enrollment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins University
Baltimore, Maryland, 21218
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Children's Hospital/Harvard
Boston, Massachusetts, 02115
University of Texas Southwestern
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Mount Sinai Beth Israel
New York, New York, 10003
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
University of California - San Diego
San Diego, California, 92093
University of Washington
Seattle, Washington, 98105
About this study
Official title: Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis: A Retrospective Analysis
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Contraception
- Keywords
- birth control, contraception, cystic fibrosis, bone mineral density, CFTR modulator, women
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary exacerbations
Annual pulmonary exacerbation rate (PEx) (defined as episodes requiring intravenous antibiotic use at home or in hospital)
Measured: 2010-2018
Secondary outcomes (8)
Lung function
Absolute change in FEV1 (in liters) measurements over time.
Measured: 2010-2018
Thromboembolism
Incidence of venous or arterial thromboembolism. Noted on self-respondent survey (defined as blood clot requiring anticoagulation treatment)
Measured: 2010-2018
Liver dysfunction
Incidence of gallstones requiring surgery, hepatic steatosis, hepatic cirrhosis and/or increased liver enzyme test values (ALT/GGT)
Measured: 2010-2018
Serum glucose trends
Incidence of insulin resistance or time to CF-related diabetes requiring insulin treatment
Measured: 2010-2018
Nutritional status
BMI trends
Measured: 2010-2018
Bone health
DXA scan determination of osteopenia or osteoporosis
Measured: 2013-2018
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
Measured: 2010-2018
Pseudomonas aeruginosa
Rate of conversion from non-mucoid to mucoid P. aeruginosa
Measured: 2010-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start30 Sep 2020
- Primary completion2 May 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Godfrey, University of Washington
- Investigators
- Emily M Godfrey, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568980
- Sponsor's protocol ID
- STUDY00008095
- Acronym
- CASE4CF
- Status last verified
- May 2023
- First submitted
- 23 Sep 2020
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04568980
- Acronym / sponsor ID
- CASE4CF / STUDY00008095
- Conditions
- Cystic Fibrosis, Contraception
- Keywords
- birth control, contraception, cystic fibrosis, bone mineral density, CFTR modulator, women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of organ transplant
- Does not have a phone number or email address in their record
- <18 years or >45 years at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary exacerbations
Time frame: 2010-2018
Annual pulmonary exacerbation rate (PEx) (defined as episodes requiring intravenous antibiotic use at home or in hospital)
8 secondary outcomes
Lung function
Time frame: 2010-2018
Thromboembolism
Time frame: 2010-2018
Liver dysfunction
Time frame: 2010-2018
Serum glucose trends
Time frame: 2010-2018
Nutritional status
Time frame: 2010-2018
Bone health
Time frame: 2013-2018
Unintended pregnancy
Time frame: 2010-2018
Pseudomonas aeruginosa
Time frame: 2010-2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily M Godfrey, MD, MPH principal investigator
University of Washington
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Contraception, run by University of Washington at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary exacerbations (time frame: 2010-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.