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NCT04568980 · ClinicalTrials.gov registry record
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
A clinical trial, sponsored by University of Washington.
- Completed
- Registry status
- 562
- Enrollment target
NCT04568980: Completed study, sponsored by University of Washington.
NCT04568980 is a clinical trial that has completed, run by University of Washington. The registered enrollment target is 562 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04568980 has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- 562 participants
- Enrollment target
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.
Primary Outcome
Annual pulmonary exacerbation rate (PEx) (defined as episodes requiring intravenous antibiotic use at home or in hospital)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2022-12-06 |
What the finished NCT04568980 record still lists
NCT04568980 is an observational study that tracks outcomes without assigning an intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04568980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04568980 about?
NCT04568980 is a clinical study titled "Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis". 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...
What is the current status of trial NCT04568980?
This trial is currently completed. The enrollment target is 562 participants. The study started on 2020-09-30. Estimated completion is 2022-12-06.
Who is sponsoring clinical trial NCT04568980?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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