Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Indiana University.
NCT03834883 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
QT intervals will be corrected for heart rate using the Fridericia method
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 |
What the finished NCT03834883 record still lists
NCT03834883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Progesterone is the first listed.
NCT03834883 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03834883's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00912041 · 27 participants · NA
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
- NCT02847559 · 27 participants · Phase 2
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
- NCT03380195 · 27 participants · NA
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness
- NCT03384238 · 27 participants · Phase 1
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI