check_circleStudy Completed

Contraception

Bayer Identifier:

91412

ClinicalTrials.gov Identifier:

NCT00185380

EudraCT Number:

2004-002291-42

EU CT Number:

Not Available
Dose-finding study for the ultralow-dose levonorgestrel intrauterine contraceptive system (LCS)

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

21 - 40 Years
  • - Women with or without children and good general health and in need of contraception.
    - Regular menstrual cycle without hormonal contraceptives.
  • - 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 summary

Enrollment Goal
742
Trial Dates
April 2005 - December 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Helsinki, 00260, Finland
Completed
Turku, 20520, Finland
Completed
Helsinki, 00100, Finland
Completed
Kuopio, 70110, Finland
Completed
Tampere, 33100, Finland
Completed
Lahti, 15110, Finland
Completed
Tampere, 33100, Finland
Completed
Oulu, 90570, Finland
Completed
Turku, 20540, Finland
Completed
Szeged, 6725, Hungary
Completed
Nyiregyhaza, 4400, Hungary
Completed
Kolbotn, 1411, Norway
Completed
Trondheim, 7014, Norway
Completed
Elverum, 2403, Norway
Completed
Larvik, 3264, Norway
Completed
Örebro, 701 46, Sweden
Completed
Luleå, 972 33, Sweden
Completed
Oulu, 90220, Finland
Completed
Oulu, 90100, Finland
Completed
Keski-Suomen keskussairaalaJyväskylä, 40620, Finland
Completed
Espoo, 02100, Finland
Completed
Turku, 20100, Finland
Completed
Joensuu, 80100, Finland
Completed
Kotka, 48100, Finland
Completed
Bekescsaba, 5600, Hungary
Completed
Eger, 3300, Hungary
Completed
Drammen, 3001, Norway
Completed
Oslo, 0309, Norway
Completed
Huddinge, 14186, Sweden
Completed
Göteborg, 411 35, Sweden
Completed
Stockholm, S-171 76, Sweden
Completed
Umeå, 90185, Sweden
Completed
Kalmar, 39231, Sweden
Completed
Chesterfield, S40 1SX, United Kingdom
Completed
Norrköping, 602 22, Sweden
Completed
Avondale SurgeryChesterfield, S40 4TF, United Kingdom
Completed
Sheffield, S1 2PJ, United Kingdom
Withdrawn
VAKK Ltd. A. Kildas Private ClinicKaunas, 3042, Lithuania
Withdrawn
Seimos meicinos centras (Private medical centre)Vilnius, 01118, Lithuania
Withdrawn
Private Clinic Narmedos medicinaVilnius, 03122, Lithuania
Withdrawn
Vaisingumo klinikaVilnius, 05263, Lithuania

Primary Outcome

  • Pearl Index
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of Subjects With Total or Partial Expulsions
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 1
    date_rangeTime Frame:
    day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 2
    date_rangeTime Frame:
    day 91 to day 180
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 3
    date_rangeTime Frame:
    day 181 to day 270
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 4
    date_rangeTime Frame:
    day 271 to day 360
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding Pattern by 90-day Reference Periods - Reference Period 12
    date_rangeTime Frame:
    day 991 to day 1080
    enhanced_encryption
    Safety Issue:
    No

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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