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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

ClinicalTrials.gov ID: NCT00528112

Public ClinicalTrials.gov record NCT00528112. 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.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 7:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT00528112
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
2,885 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 35 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2007 (Type not available)
Primary completion
Jul 2011 (Actual)
Completion
Jun 2013 (Actual)
Last update posted
Jan 25, 2017

2007 – 2013

United States locations

U.S. sites
57
U.S. states
28
U.S. cities
50
Facility City State ZIP Site status
Not listed Mobile Alabama 36608 —
Not listed Glendale Arizona 85304 —
Not listed Phoenix Arizona 85032 —
Not listed Tucson Arizona 85712 —
Not listed Carmichael California 95608 —
Not listed Pacific Palisades California 90272 —
Not listed San Diego California 92103 —
Not listed San Diego California 92108 —
Not listed San Diego California 92123 —
Not listed San Diego California 92130 —
Not listed Torrance California 90502 —
Not listed Denver Colorado 80218 —
Not listed Littleton Colorado 80128 —
Not listed Boyton Beach Florida 33472 —
Not listed Jacksonville Florida 32216 —
Not listed Miami Florida 33186 —
Not listed West Palm Beach Florida 33409 —
Not listed Atlanta Georgia 30328 —
Not listed Decatur Georgia 30034 —
Not listed Boise Idaho 83702 —
Not listed Idaho Falls Idaho 83404 —
Not listed Chicago Illinois 60612 —
Not listed Evansville Indiana 47714 —
Not listed South Bend Indiana 46601 —
Not listed Marrero Louisiana 70072 —
Not listed Boston Massachusetts 02118 —
Not listed Kalamazoo Michigan 49009 —
Not listed Chaska Minnesota 55318 —
Not listed Chesterfield Missouri 63017 —
Not listed Lincoln Nebraska 68510 —
Not listed Las Vegas Nevada 89106 —
Not listed Las Vegas Nevada 89128 —
Not listed Las Vegas Nevada 89135 —
Not listed Moorestown New Jersey 08057 —
Not listed New Brunswick New Jersey 08903-2685 —
Not listed Albuquerque New Mexico 87102 —
Not listed New York New York 10032 —
Not listed New Bern North Carolina 28562 —
Not listed Winston-Salem North Carolina 27103 —
Not listed Cincinnati Ohio 45267 —
Not listed Columbus Ohio 43213 —
Not listed Medford Oregon 97504 —
Not listed Portland Oregon 97239 —
Not listed Jenkintown Pennsylvania 19046 —
Not listed Philadelphia Pennsylvania 19114 —
Not listed Pittsburgh Pennsylvania 15206 —
Not listed Pittsburgh Pennsylvania 15213-3180 —
Not listed Columbia South Carolina 29201 —
Not listed Chattanooga Tennessee 37404 —
Not listed Memphis Tennessee 38119 —
Not listed Nashville Tennessee 37203 —
Not listed Austin Texas 78748 —
Not listed Houston Texas 77030 —
Not listed Houston Texas 77054 —
Not listed Norfolk Virginia 23507 —
Not listed Seattle Washington 98105 —
Not listed Spokane Washington 99207 —

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 79 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00528112, 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 Jan 25, 2017 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00528112 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →