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NCT02903121 · ClinicalTrials.gov registry record · Phase 4
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
A Phase 4 study of Bleeding and Breakthrough Bleeding, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 4
- Development phase
- 109
- Enrollment target
- 1
- Study location
NCT02903121: Completed Phase 4 study of Bleeding and Breakthrough Bleeding, sponsored by Oregon Health and Science University.
NCT02903121 is a Phase 4 study of Bleeding and Breakthrough Bleeding that has completed, run by Oregon Health and Science University. The registered enrollment target is 109 participants, below the 1,480-participant average among 23 other Bleeding trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02903121, a Phase 4 study of Bleeding and Breakthrough Bleeding, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 109 participants
- Enrollment target
- 1
- Study location
Study Summary
The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective method of preventing pregnancy, but it has bleeding side effects that make it unappealing for many women. The only study to demonstrate a sustained reduction in bleeding lasting for two months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary data of tamoxifen and ENG implant users, the investigators plan to perform additional studies on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.
Primary Outcome
Bleeding free days in the first 30 days
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tamoxifen
- DRUG Tamoxifen (open label)
Study Locations (1)
Oregon
- OHSU - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2017-01-20 |
| Est. Completion | 2019-06-05 |
| Phase | Phase 4 |
What the finished NCT02903121 record still lists
NCT02903121 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 1,480-participant average among 23 other Bleeding trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Bleeding appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02903121 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT02903121 about?
NCT02903121 is a clinical study titled "Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users". The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective method of preventing pregnancy, but it has bleeding side effects that make it unappealing for many women. The only study to demonstrate a sustained reduction in bleeding lasting for two months was the selectiv...
What is the current status of trial NCT02903121?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 109 participants. The study started on 2017-01-20. Estimated completion is 2019-06-05.
What conditions does trial NCT02903121 study?
This clinical trial studies the following conditions: Bleeding, Breakthrough Bleeding, Implants.
What interventions are being tested in trial NCT02903121?
The interventions under investigation include: Placebo (DRUG), Tamoxifen (DRUG), Tamoxifen (open label) (DRUG).
Who is sponsoring clinical trial NCT02903121?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02903121 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bleeding
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02903121's enrollment target sits among peer trials
109 17th of 23 higher than 7 of 23 other Bleeding trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bleeding 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.
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