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Dose-finding study for the ultralow-dose levonorgestrel intrauterine contraceptive system (LCS)
Trial ID: 91412
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.
Official Title: Multi-center, open, randomized, dose finding phase II study to investigate ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) releasing different amounts of levonorgestrel compared to MIRENA in nulliparous and parous women in need of contraception.
Product: Skyla (Levonorgestrel, BAY86-5028)
Indication/Disease: Contraception
Trial Status: Completed
Trial Start Date: 2005-04
Trial End Date: 2008-12 (Actual)
Trial Phase: Phase 2
Trial Design:
Trial Type: Interventional
Intervention: Drug
Trial Purpose: Prevention
Trial Endpoint: Safety/Efficacy Study
Allocation: Randomized
Blinding: Single Blind
Assignment: Parallel Assignment
Trial Arms: 3
Participants: 742
Primary Outcome:
  • Pearl Index
    Timeframe: Up to 3 years
Secondary Outcome:
  • Number of Subjects With Total or Partial Expulsions
    Timeframe: Up to 3 years
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 1
    Timeframe: day 1 to day 90
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 2
    Timeframe: day 91 to day 180
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 3
    Timeframe: day 181 to day 270
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 4
    Timeframe: day 271 to day 360
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 12
    Timeframe: day 991 to day 1080
Eligibility Criteria:
Minimum Age: 21 Years
Maximum Age: 40 Years
Gender: Female
Healthy Volunteers: No

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.
Additional Information: 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.
Sponsor: Bayer
United KingdomCompleted
Results Synopsis: PDF File
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