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NCT02144246 · ClinicalTrials.gov registry record · Phase 1
Contraceptive Hormones and Women With Cystic Fibrosis
A Phase 1 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02144246: Clinical Trial Phase 1 study, sponsored by University of Pennsylvania.
NCT02144246 is a Phase 1 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02144246, a Phase 1 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations. We hypothesize: 1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit, 1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception, 1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and 1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception. Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls. We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.
Primary Outcome
Satisfaction overall
Interventions
- OTHER Non-hormonal period
- DRUG Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2014-05 |
| Phase | Phase 1 |
Why NCT02144246 stopped before completion
NCT02144246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Non-hormonal period is the first listed.
NCT02144246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02144246 about?
NCT02144246 is a clinical study titled "Contraceptive Hormones and Women With Cystic Fibrosis". Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbatio...
What is the current status of trial NCT02144246?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2014-05.
What interventions are being tested in trial NCT02144246?
The interventions under investigation include: Non-hormonal period (OTHER), Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg (DRUG).
Who is sponsoring clinical trial NCT02144246?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02144246's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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