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Completed

NCT Number: NCT00528112

Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

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

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Lanús Oeste, Buenos Aires, Argentina

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About this study

Drop out-rate will be covered in Participant flow section.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LCS12

Drug

Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h

LCS16

Drug

Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Sep 12, 2007
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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