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
Drop out-rate will be covered in Participant flow section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,885
Pearl Index 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.
Time frame: Up to 3 years
Pearl Index for LCS16 up to 5 Years
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
Time frame: Up to 5 years
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1
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.
Time frame: Day 1 to Day 90
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2
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.
Time frame: Day 91 to Day 180
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3
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.
Time frame: Day 181 to Day 270
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Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
Unnamed facility
Carmichael, California, United States
Unnamed facility
Pacific Palisades, California, United States
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San Diego, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Diego, California, United States
...and 126 more locations
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4
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.
Time frame: Day 271 to Day 360
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12
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.
Time frame: Day 991 to Day 1080
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1
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.
Time frame: Day 1 to Day 30
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2
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.
Time frame: Day 31 to Day 60
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3
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.
Time frame: Day 61 to Day 90
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4
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.
Time frame: Day 91 to Day 120
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12
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.
Time frame: Day 331 to Day 360
Number of Participants With/Without Ovulation - 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.
Time frame: For six weeks in the second half of Year 1
Number of Participants With/Without Ovulation - 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.
Time frame: For six weeks in the second half of Year 2
Number of Participants With/Without Ovulation - 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.
Time frame: For six weeks in the second half of Year 3
Average Total Cervical Score - 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)
Time frame: For six weeks in the second half of Year 1
Average Total Cervical Score - 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)
Time frame: For six weeks in the second half of Year 2
Average Total Cervical Score - 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)
Time frame: For six weeks in the second half of Year 3
Classification of Endometrium - Year 1
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time frame: At Year 1
Classification of Endometrium - Year 2
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time frame: At Year 2
Classification of Endometrium - Year 3 / End of Study
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time frame: At Year 3 / End of study
Degree of User Overall Satisfaction With Study Treatment
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.
Time frame: At the end of study/Year 3
Number of Participants With Partial or Total Expulsion
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.
Time frame: Up to 3 years
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13
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.
Time frame: Day 1081 to Day 1170
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20
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.
Time frame: Day 1711 to Day 1800
Degree of User Overall Satisfaction With Study Treatment up to 5 Years
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.
Time frame: At the end of study/Year 5
Number of Participants With Partial or Total Expulsion 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.
Time frame: Up to 5 years