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Trial record 70 of 403 for:    LEVONORGESTREL

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

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ClinicalTrials.gov Identifier: NCT00185380
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : March 10, 2010
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE December 10, 2009
Results First Posted Date  ICMJE March 10, 2010
Last Update Posted Date June 10, 2015
Study Start Date  ICMJE April 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2010)
Pearl Index [ Time Frame: Up to 3 years ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Pregnancy rate after one, two and three years of use
Change History Complete list of historical versions of study NCT00185380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • Number of Subjects With Total or Partial Expulsions [ Time Frame: Up to 3 years ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • - Expulsion rate
  • - Bleeding pattern
  • - Side effects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
Official Title  ICMJE 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.
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2010)
742
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Hungary,   Norway,   Sweden,   United Kingdom
Removed Location Countries Lithuania
 
Administrative Information
NCT Number  ICMJE NCT00185380
Other Study ID Numbers  ICMJE 91412
2004-002291-42 ( EudraCT Number )
308901 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date May 2015

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