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

Bayer742 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

742

Conditions

Contraception

Interventions

Levonorgestrel IUS (BAY86-5028, G04209B)DRUG

Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years

Levonorgestrel IUS (BAY86-5028, G04209C)DRUG

Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years

Levonorgestrel IUS (Mirena, BAY86-5028)DRUG

Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (35)

Unnamed facility

Espoo, Finland

Outcomes

Primary Outcomes

Pearl Index

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.

Time frame: Up to 3 years

Secondary Outcomes

Number of Subjects With Total or Partial Expulsions

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.

Time frame: Up to 3 years

Bleeding Pattern by 90-day Reference Periods - Reference Period 1

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.

Time frame: day 1 to day 90

Bleeding Pattern by 90-day Reference Periods - Reference Period 2

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.

Time frame: day 91 to day 180

Bleeding Pattern by 90-day Reference Periods - Reference Period 3

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.

Time frame: day 181 to day 270

Bleeding Pattern by 90-day Reference Periods - Reference Period 4

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.

Data from ClinicalTrials.gov

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