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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 Sep 3, 2026, 4:10 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
Jul 31, 2007
Primary completion
Jun 30, 2011
Completion
May 31, 2013
Last update posted
Jan 24, 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 24, 2017 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00528112 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →