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NCT00528112 · ClinicalTrials.gov registry record · Phase 3
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,885
- Enrollment target
NCT00528112: Completed Phase 3 study, sponsored by Bayer.
NCT00528112 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 2,885 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (274% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00528112, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,885 participants
- Enrollment target
Study Summary
This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years
Primary Outcome
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.
Interventions
- DRUG LCS12
- DRUG LCS16
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,885 participants |
| Start Date | 2007-08 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT00528112 record still lists
NCT00528112 is an interventional study that assigns participants to a tested intervention. Its 2,885 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (274% higher).
The record links to 0 conditions, and to 2 interventions - of which LCS12 is the first listed.
NCT00528112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00528112 about?
NCT00528112 is a clinical study titled "Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study". This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The stu...
What is the current status of trial NCT00528112?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,885 participants. The study started on 2007-08. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00528112?
The interventions under investigation include: LCS12 (DRUG), LCS16 (DRUG).
Who is sponsoring clinical trial NCT00528112?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00528112's enrollment target sits among peer trials
2,885 80th of 2000 higher than 1,921 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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