LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
Public ClinicalTrials.gov record NCT01254292. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 12 µg LNG/Day Initial in Vitro Release Rate (LCS12) in Comparison to a Combined Oral Contraceptive Containing 30 µg Ethinyl Estradiol and 3 mg Drospirenone (Yasmin®) in Young Women (18-29 Years) Over 18 Months of Use
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01254292
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 567 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 29 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 6, 2011 (Actual)
- Primary completion
- Jan 8, 2013 (Actual)
- Completion
- May 28, 2014 (Actual)
- Last update posted
- Sep 25, 2017
2011 – 2014
United States locations
- U.S. sites
- 24
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Visions Clinical Research - Tucson | Tucson | Arizona | 85712 | — |
| Not listed | Tucson | Arizona | 85712 | — |
| Grossmont Center for Clinical Research | La Mesa | California | 91942 | — |
| Not listed | La Mesa | California | 91942 | — |
| Genesis Center for Clinical Research | San Diego | California | 92103 | — |
| Not listed | San Diego | California | 92103 | — |
| Medical Center for Clinical Research | San Diego | California | 92108 | — |
| Not listed | San Diego | California | 92108 | — |
| Visions Clinical Research | Boynton Beach | Florida | 33472-2952 | — |
| Not listed | Boynton Beach | Florida | 33472-2952 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Not listed | Boston | Massachusetts | 02118 | — |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | — |
| Not listed | Lincoln | Nebraska | 68510 | — |
| Columbus Center for Women's Health Research | Columbus | Ohio | 43213 | — |
| Not listed | Columbus | Ohio | 43213 | — |
| Oregon Health and Science University | Portland | Oregon | 97239-3011 | — |
| Not listed | Portland | Oregon | 97239-3011 | — |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | — |
| Not listed | Philadelphia | Pennsylvania | 19114 | — |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | — |
| Not listed | Corpus Christi | Texas | 78414 | — |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98105 | — |
| Not listed | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 70 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01254292, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2017 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01254292 live on ClinicalTrials.gov.