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

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel IUS (Mirena, BAY86-5028); Drug: Levonorgestrel IUS (BAY86-5028, G04209C); Drug: Levonorgestrel IUS (BAY86-5028, G04209B)

• Registration Number: NCT00185380
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-10
• Results First Submitted QC: 2010-02-22
• Results First Posted: 2010-03-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 742

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IUS20 (Mirena)	Levonorgestrel IUS (Mirena, BAY86-5028)	Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
LCS16	Levonorgestrel IUS (BAY86-5028, G04209C)	Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
LCS12	Levonorgestrel IUS (BAY86-5028, G04209B)	Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro

Primary Outcome Measures

Name	Time	Method
Pearl Index	Up to 3 years	The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.

Secondary Outcome Measures

Name	Time	Method
Bleeding Pattern by 90-day Reference Periods - Reference Period 12	day 991 to day 1080	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Bleeding Pattern by 90-day Reference Periods - Reference Period 2	day 91 to day 180	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Bleeding Pattern by 90-day Reference Periods - Reference Period 4	day 271 to day 360	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Number of Subjects With Total or Partial Expulsions	Up to 3 years	The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.
Bleeding Pattern by 90-day Reference Periods - Reference Period 1	day 1 to day 90	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Bleeding Pattern by 90-day Reference Periods - Reference Period 3	day 181 to day 270	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.