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Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

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ClinicalTrials.gov Identifier: NCT00528112
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : September 24, 2012
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 11, 2007
First Posted Date  ICMJE September 12, 2007
Results First Submitted Date July 11, 2012
Results First Posted Date September 24, 2012
Last Update Posted Date January 25, 2017
Study Start Date  ICMJE August 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
  • Pearl Index up to 3 Years [ Time Frame: Up to 3 years ]
    The unadjusted 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 at risk of getting pregnant.
  • Pearl Index for LCS16 up to 5 Years [ Time Frame: Up to 5 years ]
    The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2007)
Pregnancy rate [ Time Frame: 3 year treatment ]
Change History Complete list of historical versions of study NCT00528112 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1 [ Time Frame: Day 1 to Day 90 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2 [ Time Frame: Day 91 to Day 180 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3 [ Time Frame: Day 181 to Day 270 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4 [ Time Frame: Day 271 to Day 360 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12 [ Time Frame: Day 991 to Day 1080 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1 [ Time Frame: Day 1 to Day 30 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2 [ Time Frame: Day 31 to Day 60 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3 [ Time Frame: Day 61 to Day 90 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4 [ Time Frame: Day 91 to Day 120 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12 [ Time Frame: Day 331 to Day 360 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Number of Participants With/Without Ovulation - Year 1 [ Time Frame: For six weeks in the second half of Year 1 ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
  • Number of Participants With/Without Ovulation - Year 2 [ Time Frame: For six weeks in the second half of Year 2 ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
  • Number of Participants With/Without Ovulation - Year 3 [ Time Frame: For six weeks in the second half of Year 3 ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
  • Average Total Cervical Score - Year 1 [ Time Frame: For six weeks in the second half of Year 1 ]
    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
  • Average Total Cervical Score - Year 2 [ Time Frame: For six weeks in the second half of Year 2 ]
    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
  • Average Total Cervical Score - Year 3 [ Time Frame: For six weeks in the second half of Year 3 ]
    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
  • Classification of Endometrium - Year 1 [ Time Frame: At Year 1 ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
  • Classification of Endometrium - Year 2 [ Time Frame: At Year 2 ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
  • Classification of Endometrium - Year 3 / End of Study [ Time Frame: At Year 3 / End of study ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
  • Degree of User Overall Satisfaction With Study Treatment [ Time Frame: At the end of study/Year 3 ]
    Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.
  • Number of Participants With Partial or Total Expulsion [ Time Frame: Up to 3 years ]
    If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.
  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13 [ Time Frame: Day 1081 to Day 1170 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20 [ Time Frame: Day 1711 to Day 1800 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
  • Degree of User Overall Satisfaction With Study Treatment up to 5 Years [ Time Frame: At the end of study/Year 5 ]
    Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.
  • Number of Participants With Partial or Total Expulsion up to 5 Years [ Time Frame: Up to 5 years ]
    If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2007)
Drop out -rate, expulsion of the IUS, Vaginal bleeding patterns, dysmenorrhea [ Time Frame: 3 year treatment ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
Official Title  ICMJE Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years
Brief Summary This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years
Detailed Description Drop out-rate will be covered in Participant flow section.
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • Drug: LCS12
    Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
  • Drug: LCS16
    Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h
Study Arms
  • Experimental: LCS12
    Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
    Intervention: Drug: LCS12
  • Experimental: LCS16
    Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
    Intervention: Drug: LCS16
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: June 29, 2011)
2885
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2007)
2820
Actual Study Completion Date June 2013
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
  • Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Exclusion Criteria:

  • Known or suspected pregnancy or is lactating.
  • History of ectopic pregnancies.
  • Any genital infection (until successfully treated).
  • Abnormal uterine bleeding of unknown origin.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Chile,   Finland,   France,   Hungary,   Mexico,   Netherlands,   Norway,   Sweden,   United States
Removed Location Countries Brazil,   Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT00528112
Other Study ID Numbers  ICMJE 91665
310442 ( Other Identifier: Company internal )
G04209F ( Other Identifier: Company internal )
G04209G ( Other Identifier: Company internal )
2007-000420-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement 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 December 2016

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