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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:
Bayer
ClinicalTrials.gov Identifier:
NCT00185380
First received: September 13, 2005
Last updated: May 25, 2012
Last verified: May 2012
History of Changes

September 13, 2005
May 25, 2012
April 2005
December 2008   (final data collection date for primary outcome measure)
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.
Pregnancy rate after one, two and three years of use
Complete list of historical versions of study NCT00185380 on ClinicalTrials.gov Archive Site
  • 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.
  • - Expulsion rate
  • - Bleeding pattern
  • - Side effects
Not Provided
Not Provided
 
Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Contraception
  • Drug: Levonorgestrel IUS (BAY86-5028, G04209B)
    Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years
  • Drug: Levonorgestrel IUS (BAY86-5028, G04209C)
    Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years
  • Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
    Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years
  • Experimental: LCS12
    Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
    Intervention: Drug: Levonorgestrel IUS (BAY86-5028, G04209B)
  • Experimental: LCS16
    Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
    Intervention: Drug: Levonorgestrel IUS (BAY86-5028, G04209C)
  • Active Comparator: IUS20 (Mirena)
    Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
    Intervention: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012 Mar;97(3):616-22.e1-3. Epub 2012 Jan 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
742
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Female
21 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Hungary,   Norway,   Sweden,   United Kingdom
 
NCT00185380
91412, 2004-002291-42, 308901
No
Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP