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Trial record 1 of 1 for:    NCT00528112
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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Contraception Drug: LCS12 Drug: LCS16 Phase 3

Detailed Description:
Drop out-rate will be covered in Participant flow section.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2885 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
Experimental: LCS12
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
 Drug: LCS12
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
Experimental: LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
 Drug: LCS16
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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)

  15. 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)


  16. 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)

  17. Classification of Endometrium - Year 1 [ Time Frame: At Year 1 ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium

  18. Classification of Endometrium - Year 2 [ Time Frame: At Year 2 ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium

  19. 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

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528112


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00528112    
Other Study ID Numbers: 91665
310442 ( Other Identifier: Company internal )
G04209F ( Other Identifier: Company internal )
G04209G ( Other Identifier: Company internal )
2007-000420-40 ( EudraCT Number )
First Posted: September 12, 2007    Key Record Dates
Results First Posted: September 24, 2012
Last Update Posted: January 25, 2017
Last Verified: December 2016
Keywords provided by Bayer:
Contraception
Intrauterine
IUD
IUS