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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Contraception
Interventions Drug: LCS12
Drug: LCS16
Enrollment 2885
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years. Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
Period Title: Treatment up to 3 Years
Started 1432 1453
Participants Received Treatment 1432 [1] 1452 [1]
Completed 819 870
Not Completed 613 583
Reason Not Completed
Adverse Event             313             278
Withdrawal by Subject             26             31
Protocol Violation             16             16
Death             0             1
Lost to Follow-up             63             61
Pregnancy             9             10
Other reasons             186             186
[1]
Full analysis set/Safety population
Period Title: Extension Phase
Started 0 [1] 707
Completed 0 550
Not Completed 0 157
Reason Not Completed
Withdrawal by Subject             0             3
Other reasons             0             100
Pregnancy             0             3
Lost to Follow-up             0             12
Death             0             1
Adverse Event             0             36
Protocol Violation             0             2
[1]
Only subjects in the LCS16 groups could participate in the extension phase
Arm/Group Title LCS12 LCS16 Total
Hide Arm/Group Description Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro Total of all reporting groups
Overall Number of Baseline Participants 1432 1452 2884
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1432 participants 1452 participants 2884 participants
27.2
(18 to 35)
27.1
(18 to 35)
27.1
(18 to 35)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1432 participants 1452 participants 2884 participants
≤ 25 years 566 564 1130
> 25 years ≤ 35 years 866 888 1754
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1432 participants 1452 participants 2884 participants
Female
1432
 100.0%
1452
 100.0%
2884
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Pearl Index up to 3 Years
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1432 1452
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pregnancies per 100 women years
0.33
(0.16 to 0.60)
0.31
(0.15 to 0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCS12
Comments Cumulative failure rate (Kaplan-Meier) at 3 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter failure rate
Estimated Value 0.009
Confidence Interval (2-Sided) 95%
0.005 to 0.017
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LCS16
Comments Cumulative failure rate (Kaplan-Meier) at 3 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter failure rate
Estimated Value 0.010
Confidence Interval 95%
0.005 to 0.018
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pearl Index for LCS16 up to 5 Years
Hide Description The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1452
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pregnancies per 100 women years
0.29
(0.16 to 0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCS16
Comments Cumulative failure rate (Kaplan-Meier) at 5 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter failure rate
Estimated Value 0.01445
Confidence Interval (2-Sided) 95%
0.00823 to 0.02531
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1322 1348
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 40.9  (19.1) 39.7  (19.2)
Number of bleeding days 18.3  (12.3) 17.7  (13.2)
Number of spotting only days 22.6  (14.1) 21.9  (14.0)
4.Secondary Outcome
Title Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1262 1300
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 23.3  (14.8) 21.1  (15.1)
Number of bleeding days 10.2  (8.7) 8.7  (9.1)
Number of spotting only days 13.2  (10.4) 12.3  (10.4)
5.Secondary Outcome
Title Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1192 1238
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 19.4  (13.2) 16.3  (12.8)
Number of bleeding days 8.3  (8.2) 6.3  (7.5)
Number of spotting only days 11.2  (9.0) 10.0  (8.8)
6.Secondary Outcome
Title Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1123 1175
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 17.6  (12.1) 14.3  (11.8)
Number of bleeding days 7.2  (7.2) 5.1  (6.6)
Number of spotting only days 10.4  (8.3) 9.1  (8.2)
7.Secondary Outcome
Title Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 770 819
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 13.4  (9.9) 10.2  (9.5)
Number of bleeding days 4.8  (5.9) 3.3  (5.3)
Number of spotting only days 8.6  (7.1) 6.9  (6.8)
8.Secondary Outcome
Title Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1355 1376
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 18.0  (8.0) 17.3  (8.0)
Number of bleeding days 8.2  (6.0) 8.1  (6.3)
Number of spotting only days 9.7  (6.5) 9.2  (6.4)
9.Secondary Outcome
Title Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1345 1375
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 12.7  (7.6) 12.9  (8.0)
Number of bleeding days 5.6  (4.9) 5.5  (5.3)
Number of spotting only days 7.1  (5.9) 7.3  (6.2)
10.Secondary Outcome
Title Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1328 1355
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 10.3  (6.9) 9.5  (7.0)
Number of bleeding days 4.4  (4.1) 4.1  (4.5)
Number of spotting only days 5.8  (5.2) 5.4  (5.2)
11.Secondary Outcome
Title Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1300 1334
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 8.6  (6.0) 7.8  (6.2)
Number of bleeding days 3.7  (3.6) 3.2  (3.6)
Number of spotting only days 4.9  (4.5) 4.6  (4.6)
12.Secondary Outcome
Title Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1130 1186
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 5.7  (4.7) 4.6  (4.4)
Number of bleeding days 2.3  (2.8) 1.6  (2.5)
Number of spotting only days 3.4  (3.4) 3.0  (3.1)
13.Secondary Outcome
Title Number of Participants With/Without Ovulation – Year 1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 14 12
Measure Type: Number
Unit of Measure: Participants
With ovulation 13 11
Without ovulation 1 1
14.Secondary Outcome
Title Number of Participants With/Without Ovulation – Year 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 11 10
Measure Type: Number
Unit of Measure: Participants
With ovulation 10 9
Without ovulation 1 1
15.Secondary Outcome
Title Number of Participants With/Without Ovulation – Year 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 11 7
Measure Type: Number
Unit of Measure: Participants
With ovulation 11 7
Without ovulation 0 0
16.Secondary Outcome
Title Average Total Cervical Score – Year 1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.067  (1.291) 3.127  (1.620)
17.Secondary Outcome
Title Average Total Cervical Score – Year 2
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.358  (1.272) 2.798  (1.499)
18.Secondary Outcome
Title Average Total Cervical Score – Year 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 10 6
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.837  (1.354) 2.448  (1.521)
19.Secondary Outcome
Title Classification of Endometrium – Year 1
Hide Description The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time Frame At Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 26 23
Measure Type: Number
Unit of Measure: Participants
Atrophic/inactive 0 0
Proliferative 0 0
Secretory 25 22
Menstrual 0 0
Unclassified 1 1
20.Secondary Outcome
Title Classification of Endometrium – Year 2
Hide Description The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 22 19
Measure Type: Number
Unit of Measure: Participants
Atrophic/inactive 0 0
Proliferative 0 0
Secretory 19 19
Menstrual 0 0
Unclassified 3 0
21.Secondary Outcome
Title Classification of Endometrium – Year 3 / End of Study
Hide Description The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time Frame At Year 3 / End of study
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of women from the full analysis set
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 25 23
Measure Type: Number
Unit of Measure: Participants
Atrophic/inactive 0 0
Proliferative 0 1
Secretory 24 22
Menstrual 0 0
Unclassified 1 0
22.Secondary Outcome
Title Degree of User Overall Satisfaction With Study Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1053 1063
Measure Type: Number
Unit of Measure: Participants
Missing 1 1
Very satisfied 796 842
Somewhat satisfied 201 177
Neither satisfied / dissatisfied 31 22
Dissatisfied 23 18
Very dissatisfied 1 3
23.Secondary Outcome
Title Number of Participants With Partial or Total Expulsion
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS12 LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1426 1445
Measure Type: Number
Unit of Measure: Participants
IUS partially expelled 24 30
IUS totally expelled 29 16
24.Secondary Outcome
Title Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 617
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 9.6  (9.0)
Number of bleeding days 3.1  (4.8)
Number of spotting only days 6.6  (6.4)
25.Secondary Outcome
Title Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 531
Mean (Standard Deviation)
Unit of Measure: Days
Number of bleeding/spotting days 9.3  (8.8)
Number of bleeding days 2.9  (4.9)
Number of spotting only days 6.4  (6.1)
26.Secondary Outcome
Title Degree of User Overall Satisfaction With Study Treatment up to 5 Years
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who participated in the extension phase and had an assessment for this evaluation
Arm/Group Title LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 686
Measure Type: Number
Unit of Measure: Participants
Very satisfied 610
Somewhat satisfied 70
Neither satisfied / dissatisfied 3
Dissatisfied 1
Very dissatisfied 2
27.Secondary Outcome
Title Number of Participants With Partial or Total Expulsion up to 5 Years
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the full analysis set who had an assessment for this evaluation
Arm/Group Title LCS16
Hide Arm/Group Description:
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Overall Number of Participants Analyzed 1445
Measure Type: Number
Unit of Measure: Participants
IUS partially expelled 35
IUS totally expelled 19
Time Frame From start of treatment until end of study, up to 5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCS12, up to 3 Years LCS16, up to 3 Years LCS16, up to 5 Years
Hide Arm/Group Description Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years. Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years. Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
All-Cause Mortality
LCS12, up to 3 Years LCS16, up to 3 Years LCS16, up to 5 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LCS12, up to 3 Years LCS16, up to 3 Years LCS16, up to 5 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/1432 (4.61%)   72/1452 (4.96%)   86/1452 (5.92%) 
Blood and lymphatic system disorders       
Spherocytic anaemia * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Splenomegaly * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Cardiac disorders       
Mitral valve prolapse * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Sinus tachycardia * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Ear and labyrinth disorders       
Vertigo * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Endocrine disorders       
Goitre * 1  1/1432 (0.07%)  1/1452 (0.07%)  1/1452 (0.07%) 
Eye disorders       
Iridocyclitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Gastrointestinal disorders       
Abdominal adhesions * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Abdominal pain * 1  4/1432 (0.28%)  4/1452 (0.28%)  4/1452 (0.28%) 
Constipation * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Crohn's disease * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Dyspepsia * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Dysphagia * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Gastritis * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Gastrointestinal disorder * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Impaired gastric emptying * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Irritable bowel syndrome * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Odynophagia * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Rectal haemorrhage * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Salivary gland calculus * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Umbilical hernia * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Abdominal hernia * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
General disorders       
Chest pain * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Pyrexia * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Device dislocation * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Hepatobiliary disorders       
Cholecystitis * 1  2/1432 (0.14%)  2/1452 (0.14%)  2/1452 (0.14%) 
Cholecystitis chronic * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Cholelithiasis * 1  1/1432 (0.07%)  2/1452 (0.14%)  2/1452 (0.14%) 
Gallbladder polyp * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Immune system disorders       
Anaphylactic reaction * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Drug hypersensitivity * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Infections and infestations       
Appendicitis * 1  6/1432 (0.42%)  7/1452 (0.48%)  8/1452 (0.55%) 
Campylobacter gastroenteritis * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Cellulitis * 1  1/1432 (0.07%)  1/1452 (0.07%)  1/1452 (0.07%) 
Cystitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Diverticulitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Gastroenteritis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Genital herpes * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Infection * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Influenza * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Meningitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  1/1452 (0.07%) 
Meningitis viral * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Pelvic inflammatory disease * 1  2/1432 (0.14%)  4/1452 (0.28%)  5/1452 (0.34%) 
Peritoneal abscess * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Peritonitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Peritonsillar abscess * 1  1/1432 (0.07%)  1/1452 (0.07%)  1/1452 (0.07%) 
Pneumonia * 1  2/1432 (0.14%)  1/1452 (0.07%)  2/1452 (0.14%) 
Pyelonephritis * 1  1/1432 (0.07%)  1/1452 (0.07%)  1/1452 (0.07%) 
Pyelonephritis acute * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Sinusitis * 1  0/1432 (0.00%)  1/1452 (0.07%)  2/1452 (0.14%) 
Tonsillitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Upper respiratory tract infection * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Urinary tract infection * 1  2/1432 (0.14%)  0/1452 (0.00%)  0/1452 (0.00%) 
Vestibular neuronitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Viral infection * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Streptococcal sepsis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Tubo-ovarian abscess * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Enterocolitis infectious * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Herpes dermatitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Foot fracture * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Forearm fracture * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Ligament sprain * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Multiple injuries * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Overdose * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Subdural haematoma * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Tendon rupture * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Uterine perforation * 1  0/1432 (0.00%)  1/1452 (0.07%)  2/1452 (0.14%) 
Thermal burn * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Pelvic fracture * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Procedural pain * 1  0/1432 (0.00%)  2/1452 (0.14%)  2/1452 (0.14%) 
Meniscus injury * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Investigations       
Haemoglobin decreased * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Weight increased * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Metabolism and nutrition disorders       
Diabetic ketoacidosis * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Musculoskeletal and connective tissue disorders       
Arthritis * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Loose body in joint * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Synovitis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Axillary mass * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Intervertebral disc protrusion * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Joint instability * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute leukaemia * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Ovarian germ cell teratoma benign * 1  2/1432 (0.14%)  2/1452 (0.14%)  2/1452 (0.14%) 
Pancreatic carcinoma * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Uterine leiomyoma * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Teratoma benign * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Cervix carcinoma stage 0 * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Astrocytoma, low grade * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Thyroid cancer * 1  2/1432 (0.14%)  0/1452 (0.00%)  0/1452 (0.00%) 
Nervous system disorders       
Convulsion * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Dizziness * 1  0/1432 (0.00%)  2/1452 (0.14%)  2/1452 (0.14%) 
Headache * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Migraine * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Multiple sclerosis * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Paraesthesia * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Sciatica * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Trigeminal neuralgia * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Status migrainosus * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion missed * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Abortion spontaneous * 1  3/1432 (0.21%)  0/1452 (0.00%)  0/1452 (0.00%) 
Blighted ovum * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Ectopic pregnancy * 1  3/1432 (0.21%)  6/1452 (0.41%)  7/1452 (0.48%) 
Premature separation of placenta * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Ruptured ectopic pregnancy * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Abortion spontaneous incomplete * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Psychiatric disorders       
Affective disorder * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Alcoholism * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Anxiety * 1  1/1432 (0.07%)  1/1452 (0.07%)  1/1452 (0.07%) 
Completed suicide * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Depression * 1  1/1432 (0.07%)  1/1452 (0.07%)  3/1452 (0.21%) 
Depression suicidal * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Drug dependence * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Hallucination, auditory * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Panic reaction * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Suicide attempt * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Polysubstance dependence * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Bipolar disorder * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Renal and urinary disorders       
Haematuria * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Strangury * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Stress urinary incontinence * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Reproductive system and breast disorders       
Endometriosis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Ovarian cyst * 1  1/1432 (0.07%)  2/1452 (0.14%)  2/1452 (0.14%) 
Ovarian cyst ruptured * 1  1/1432 (0.07%)  1/1452 (0.07%)  1/1452 (0.07%) 
Pelvic adhesions * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Uterine prolapse * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Uterine spasm * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Ovarian cyst torsion * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Haemorrhagic ovarian cyst * 1  2/1432 (0.14%)  0/1452 (0.00%)  0/1452 (0.00%) 
Vaginal perforation * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/1432 (0.07%)  1/1452 (0.07%)  1/1452 (0.07%) 
Dyspnoea * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Hypoxia * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Pneumothorax * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Skin and subcutaneous tissue disorders       
Erythema multiforme * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
Urticaria * 1  0/1432 (0.00%)  1/1452 (0.07%)  1/1452 (0.07%) 
Surgical and medical procedures       
Detoxification * 1  1/1432 (0.07%)  1/1452 (0.07%)  1/1452 (0.07%) 
Vascular disorders       
Hypertension * 1  1/1432 (0.07%)  0/1452 (0.00%)  1/1452 (0.07%) 
Varicose vein * 1  0/1432 (0.00%)  0/1452 (0.00%)  1/1452 (0.07%) 
Deep vein thrombosis * 1  1/1432 (0.07%)  0/1452 (0.00%)  0/1452 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LCS12, up to 3 Years LCS16, up to 3 Years LCS16, up to 5 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   952/1432 (66.48%)   1014/1452 (69.83%)   1054/1452 (72.59%) 
Gastrointestinal disorders       
Abdominal pain * 1  96/1432 (6.70%)  98/1452 (6.75%)  102/1452 (7.02%) 
Abdominal pain lower * 1  67/1432 (4.68%)  62/1452 (4.27%)  74/1452 (5.10%) 
Nausea * 1  74/1432 (5.17%)  58/1452 (3.99%)  59/1452 (4.06%) 
Infections and infestations       
Influenza * 1  72/1432 (5.03%)  92/1452 (6.34%)  100/1452 (6.89%) 
Nasopharyngitis * 1  103/1432 (7.19%)  109/1452 (7.51%)  122/1452 (8.40%) 
Sinusitis * 1  90/1432 (6.28%)  96/1452 (6.61%)  107/1452 (7.37%) 
Urinary tract infection * 1  156/1432 (10.89%)  148/1452 (10.19%)  167/1452 (11.50%) 
Vaginal infection * 1  48/1432 (3.35%)  62/1452 (4.27%)  73/1452 (5.03%) 
Vulvovaginal candidiasis * 1  72/1432 (5.03%)  74/1452 (5.10%)  86/1452 (5.92%) 
Vaginitis bacterial * 1  105/1432 (7.33%)  128/1452 (8.82%)  150/1452 (10.33%) 
Vulvovaginal mycotic infection * 1  99/1432 (6.91%)  108/1452 (7.44%)  126/1452 (8.68%) 
Investigations       
Weight increased * 1  56/1432 (3.91%)  71/1452 (4.89%)  76/1452 (5.23%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  59/1432 (4.12%)  65/1452 (4.48%)  80/1452 (5.51%) 
Nervous system disorders       
Headache * 1  132/1432 (9.22%)  137/1452 (9.44%)  146/1452 (10.06%) 
Reproductive system and breast disorders       
Cervical dysplasia * 1  107/1432 (7.47%)  116/1452 (7.99%)  147/1452 (10.12%) 
Dysmenorrhoea * 1  130/1432 (9.08%)  109/1452 (7.51%)  116/1452 (7.99%) 
Ovarian cyst * 1  186/1432 (12.99%)  303/1452 (20.87%)  337/1452 (23.21%) 
Pelvic pain * 1  96/1432 (6.70%)  122/1452 (8.40%)  132/1452 (9.09%) 
Vaginal haemorrhage * 1  66/1432 (4.61%)  73/1452 (5.03%)  80/1452 (5.51%) 
Skin and subcutaneous tissue disorders       
Acne * 1  163/1432 (11.38%)  170/1452 (11.71%)  179/1452 (12.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal investigators (PIs) have to send the publication to sponsor 90 days prior to planned publishing. The sponsor has maximum 60 days for review and for recommending changes or mark parts that have to be deleted from the publication due to harming sponsor’s confidentiality rights. Sponsor can request a delay in publication release up to 6 months.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00528112     History of Changes
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 Submitted: September 11, 2007
First Posted: September 12, 2007
Results First Submitted: July 11, 2012
Results First Posted: September 24, 2012
Last Update Posted: January 25, 2017