Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Levonorgestrel

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Known or suspected pregnancy or is lactating.

• History of ectopic pregnancies.

• Any genital infection (until successfully treated).

• Abnormal uterine bleeding of unknown origin.