Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: LCS12; Drug: LCS16

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528112

2007-000420-40 (EudraCT Number)

G04209F (Other Identifier)

91665

310442 (Other Identifier)

G04209G (Other Identifier)

Details and patient eligibility

About

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

Full description

Drop out-rate will be covered in Participant flow section.

Enrollment: 2,885 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,885 participants in 2 patient groups

LCS12

Experimental group

Description:

Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro

Treatment:

Drug: LCS12

LCS16

Experimental group

Description:

Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro

Treatment:

Drug: LCS16