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NCT03834883 · ClinicalTrials.gov registry record · Phase 4
Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT03834883 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 27 participants.
The verdict
NCT03834883, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
This research will determine if oral progesterone attenuates drug-induced QT interval lengthening in a) Postmenopausal women 50 years of age or older, and b) Premenopausal women studied during the ovulation phase of the menstrual cycle. This investigation will consist of two concurrent prospective, randomized, double-blind, placebo-controlled crossover-design studies in a) Postmenopausal women, and b) Premenopausal women. Each subject will take progesterone or placebo capsules for 1 week. After a two-week "washout" (no progesterone or placebo) each subject will then take the alternative therapy (progesterone or placebo) for 1 week. After 7 days of each treatment, subjects will present to the clinical research center to receive a small dose of the QT interval-lengthening drug ibutilide, and the effect on the QT, J-Tpeak and Tpeak-Tend intervals during the progesterone and placebo phases will be compared
Interventions
- DRUG Progesterone
- DRUG Ibutilide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03834883
The ClinicalTrials.gov registry entry for NCT03834883 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Progesterone is the first listed.
NCT03834883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03834883 about?
NCT03834883 is a clinical study titled "Reducing the Risk of Drug-Induced QT Interval Lengthening in Women". This research will determine if oral progesterone attenuates drug-induced QT interval lengthening in a) Postmenopausal women 50 years of age or older, and b) Premenopausal women studied during the ovulation phase of the menstrual cycle. This investigation will consist of two concurrent prospective, ...
What is the current status of trial NCT03834883?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2019-03-26. Estimated completion is 2024-05-23.
What interventions are being tested in trial NCT03834883?
The interventions under investigation include: Progesterone (DRUG), Ibutilide (DRUG).
Who is sponsoring clinical trial NCT03834883?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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