Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

Bayer

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: Levonorgestrel IUS (BAY86-5028, G04209B); Drug: Levonorgestrel IUS (BAY86-5028, G04209C); Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185380

308901 (Other Identifier)

91412

2004-002291-42 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Although the title of the study describes "open", it was in fact single-blinded.

Issues on side effects are addressed in the Adverse Event section.

Enrollment: 742 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with or without children and good general health and in need of contraception.
• Regular menstrual cycle without hormonal contraceptives.

Exclusion criteria

• Pregnant or lactating.
• Last delivery or abortion less than 12 weeks ago.
• Previous pregnancies outside the womb.
• Previous pelvic infections.
• Abnormal bleeding.
• Abnormal uterine cavity.
• Climacteric signs.
• Genital cancer.
• Liver diseases.
• Alcoholism or drug abuse.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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742 participants in 3 patient groups

LCS12

Experimental group

Description:

Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro

Treatment:

Drug: Levonorgestrel IUS (BAY86-5028, G04209B)

LCS16

Experimental group

Description:

Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro

Treatment:

Drug: Levonorgestrel IUS (BAY86-5028, G04209C)

IUS20 (Mirena)

Active Comparator group

Description:

Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro

Treatment:

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)