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NCT01254292 · ClinicalTrials.gov registry record · Phase 3
LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 567
- Enrollment target
NCT01254292 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 567 participants.
The verdict
NCT01254292, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 567 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study. Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index \[PI\]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.
Interventions
- DRUG Levonorgestrel IUD (LCS, BAY86-5028)
- DRUG Yasmin (EE30/DRSP, BAY86-5131)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 567 participants |
| Start Date | 2011-01-06 |
| Est. Completion | 2014-05-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01254292
The ClinicalTrials.gov registry entry for NCT01254292 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 567 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Levonorgestrel IUD (LCS, BAY86-5028) is the first listed.
NCT01254292 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01254292 about?
NCT01254292 is a clinical study titled "LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study". The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended...
What is the current status of trial NCT01254292?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 567 participants. The study started on 2011-01-06. Estimated completion is 2014-05-28.
What interventions are being tested in trial NCT01254292?
The interventions under investigation include: Levonorgestrel IUD (LCS, BAY86-5028) (DRUG), Yasmin (EE30/DRSP, BAY86-5131) (DRUG).
Who is sponsoring clinical trial NCT01254292?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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