Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
- Registration Number
- NCT00528112
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2885
- 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).
- Known or suspected pregnancy or is lactating.
- History of ectopic pregnancies.
- Any genital infection (until successfully treated).
- Abnormal uterine bleeding of unknown origin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LCS12 LCS12 Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro LCS16 LCS16 Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
- Primary Outcome Measures
Name Time Method Pearl Index up to 3 Years 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 Up to 5 years The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
- Secondary Outcome Measures
Name Time Method Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 At Year 1 The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Classification of Endometrium - Year 2 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 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 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 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 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 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 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 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.