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NCT02036879 · ClinicalTrials.gov registry record · Early Phase 1
Gender Disparity and Hormones in Cystic Fibrosis
A Early Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 55
- Enrollment target
NCT02036879: Completed Early Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT02036879 is a Early Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 55 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02036879, a Early Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
The objective of this study is to investigate the impact of hormones on lung disease in Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and healthier lives than they did 20 years ago. However, females have been shown to have a survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The hypothesis is that estrogen and/or progesterone negatively impact lung health in CF. Therefore, understanding the impact of sex hormones (including the use of birth control pills) on the disease process is increasingly important. The purpose of this study is to determine if lung function, respiratory symptoms, or various markers of lung health change during different phases of the natural ovulatory cycle in order to understand if estrogen or progesterone hormones are impacting the disease relative to fluctuations in men with stable testosterone levels. The research objectives of this project are to: * Determine if lung function, respiratory symptoms, or various markers of lung health change during different hormonal phases of the ovulatory cycle in women. * Determine if men change lung function, respiratory symptoms, or various markers of lung health over time. * Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and improve lung health.
Interventions
- DRUG Loestrin (norethindrone acetate and ethinyl estradiol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-08 |
| Phase | Early Phase 1 |
What the finished NCT02036879 record still lists
NCT02036879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Loestrin (norethindrone acetate and ethinyl estradiol) is the first listed.
NCT02036879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02036879 about?
NCT02036879 is a clinical study titled "Gender Disparity and Hormones in Cystic Fibrosis". The objective of this study is to investigate the impact of hormones on lung disease in Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and healthier lives than they did 20 years ago. However, females have been shown to have a survival disadvantage. The median...
What is the current status of trial NCT02036879?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 55 participants. The study started on 2014-02. Estimated completion is 2018-08.
What interventions are being tested in trial NCT02036879?
The interventions under investigation include: Loestrin (norethindrone acetate and ethinyl estradiol) (DRUG).
Who is sponsoring clinical trial NCT02036879?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02036879's enrollment target sits among peer trials
55 458th of 2000 higher than 1,537 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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