Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02144246
The ClinicalTrials.gov registry entry for NCT02144246 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Non-hormonal period is the first listed.
NCT02144246 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.