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NCT01963403 · ClinicalTrials.gov registry record · Phase 4
Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
A Phase 4 study, sponsored by University of California, Davis.
- Terminated
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01963403: Clinical Trial Phase 4 study, sponsored by University of California, Davis.
NCT01963403 is a Phase 4 study that was terminated before completion, run by University of California, Davis. The registered enrollment target is 26 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
NCT01963403, a Phase 4 study, was terminated before completion, sponsored by University of California, Davis.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant. The hypothesis of the study is: * Use of combined oral contraceptive will significantly improve bleeding patterns for users of ETG implant * Continuation rate of ETG implant users will be increased by use of combined oral contraceptive in women desiring ETG implant removal because of the undesirable bleeding * Adverse events will be uncommon and acceptable to women who use a combined oral contraceptive with the ETG implant
Primary Outcome
Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.
Interventions
- DRUG Placebo
- DRUG EE 30mcg/LNG 150mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
Why NCT01963403 stopped before completion
NCT01963403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 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 Placebo is the first listed.
NCT01963403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01963403 about?
NCT01963403 is a clinical study titled "Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive". This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant. The hypothesis of the study ...
What is the current status of trial NCT01963403?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2013-12. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01963403?
The interventions under investigation include: Placebo (DRUG), EE 30mcg/LNG 150mcg (DRUG).
Who is sponsoring clinical trial NCT01963403?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01963403's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 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
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