Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00567164 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,887
- Enrollment target
NCT00567164: Completed Phase 3 study, sponsored by Bayer.
NCT00567164 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,887 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00567164, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,887 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the study drug is safe and effective.
Primary Outcome
The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the
Interventions
- DRUG EE20/DRSP (BAY86-5300)
- DRUG EE20/DRSP (YAZ, BAY86-5300)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,887 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
What the finished NCT00567164 record still lists
NCT00567164 is an interventional study that assigns participants to a tested intervention. Its 1,887 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 (144% higher).
The record links to 0 conditions, and to 2 interventions - of which EE20/DRSP (BAY86-5300) is the first listed.
NCT00567164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00567164 about?
NCT00567164 is a clinical study titled "Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ". The purpose of this study is to determine whether the study drug is safe and effective.
What is the current status of trial NCT00567164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,887 participants. The study started on 2007-10. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00567164?
The interventions under investigation include: EE20/DRSP (BAY86-5300) (DRUG), EE20/DRSP (YAZ, BAY86-5300) (DRUG).
Who is sponsoring clinical trial NCT00567164?
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 NCT00567164's enrollment target sits among peer trials
1,887 113th of 2000 higher than 1,888 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
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
- NCT06438640 · 1,881 participants · NA
Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
- NCT07308717 · 1,896 participants · Phase 4
Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol
- NCT05675410 · 1,875 participants · Phase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
- NCT06891898 · 1,875 participants
The iLet Experience Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia