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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: Completed Phase 3 study, sponsored by Bayer.
NCT01254292 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 567 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.
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 |
What the finished NCT01254292 record still lists
NCT01254292 is an interventional study that assigns participants to a tested intervention. The registered 567 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Levonorgestrel IUD (LCS, BAY86-5028) is the first listed.
NCT01254292 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01254292's enrollment target sits among peer trials
567 667th of 2000 higher than 1,334 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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