Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

Completed · Phase 3

Conditions studied: Contraception

In brief

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

Key facts

Study ID

NCT00528112

Run by

Bayer

People needed

2885

Starts

2007-08-01

Expected to finish

2013-06-01

Last updated by the study team

2017-01-25

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
• Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

You may not qualify if…

• Known or suspected pregnancy or is lactating.
• History of ectopic pregnancies.
• Any genital infection (until successfully treated).
• Abnormal uterine bleeding of unknown origin.

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Carmichael, California, United States
• Study site — Pacific Palisades, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Boyton Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — South Bend, Indiana, United States
• Study site — Marrero, Louisiana, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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