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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00185380
First received: September 13, 2005
Last updated: May 21, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Contraception
Drug: Levonorgestrel IUS (BAY86-5028, G04209B)
Drug: Levonorgestrel IUS (BAY86-5028, G04209C)
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pearl Index [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Number of Subjects With Total or Partial Expulsions [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 1 to day 90 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 91 to day 180 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 181 to day 270 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 271 to day 360 ] [ Designated as safety issue: No ]
    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 12 [ Time Frame: day 991 to day 1080 ] [ Designated as safety issue: No ]
    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.


Enrollment: 742
Study Start Date: April 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCS12
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
Drug: Levonorgestrel IUS (BAY86-5028, G04209B)
Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years
Experimental: LCS16
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
Drug: Levonorgestrel IUS (BAY86-5028, G04209C)
Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years
Active Comparator: IUS20 (Mirena)
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years

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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185380

Locations
Finland
Espoo, Finland, 02100
Helsinki, Finland, 00100
Joensuu, Finland, 80100
Jyväskylä, Finland, 40620
Kotka, Finland, 48100
Kuopio, Finland, 70110
Lahti, Finland, 15110
Oulu, Finland, 90100
Oulu, Finland, 90570
Oulu, Finland, 90220
Tampere, Finland, 33100
Turku, Finland, 20540
Turku, Finland, 20100
Turku, Finland, 20520
Hungary
Bekescsaba, Hungary, 5600
Eger, Hungary, 3300
Nyiregyhaza, Hungary, 4400
Szeged, Hungary, 6725
Norway
Drammen, Norway, 3001
Elverum, Norway, 2403
Kolbotn, Norway, 1411
Larvik, Norway, 3264
Oslo, Norway, 0309
Trondheim, Norway, 7014
Sweden
Göteborg, Sweden, 411 35
Huddinge, Sweden, 14186
Kalmar, Sweden, 39231
Luleå, Sweden, 972 33
Norrköping, Sweden, 602 22
Stockholm, Sweden, S-171 76
Umea, Sweden, 90185
Örebro, Sweden, 701 46
United Kingdom
Chesterfield, Derbyshire, United Kingdom, S40 4TF
Sheffield, South Yorkshire, United Kingdom, S1 2PJ
Chesterfield, United Kingdom, S40 1SX
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185380     History of Changes
Other Study ID Numbers: 91412, 2004-002291-42, 308901
Study First Received: September 13, 2005
Results First Received: December 10, 2009
Last Updated: May 21, 2014
Health Authority: Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Lithuania: State Medicine Control Agency - Ministry of Health
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014