Trial Outcomes & Findings for Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS) (NCT NCT00185380)
NCT ID: NCT00185380
Last Updated: 2015-06-10
Results Overview
The 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 under risk of getting pregnant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
742 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2015-06-10
Participant Flow
Parous or nulliparous women in good general health and in need of contraception were recruited from medical clinics between April and Nov 2005.
Most screening failures were in-/exclusion criteria not met and over-screening. Randomized: 742 women, Treated: 738 women. Full analysis set (FAS), safety analysis set (SAF) and per protocol analysis set (PPS) were identical (738 subjects).
Participant milestones
| Measure |
LCS12
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Overall Study
STARTED
|
240
|
246
|
256
|
|
Overall Study
Subjects Received Treatment
|
239
|
245
|
254
|
|
Overall Study
COMPLETED
|
174
|
174
|
182
|
|
Overall Study
NOT COMPLETED
|
66
|
72
|
74
|
Reasons for withdrawal
| Measure |
LCS12
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
41
|
43
|
48
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
3
|
|
Overall Study
Pregnancy
|
1
|
4
|
0
|
|
Overall Study
Protocol Violation
|
2
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Failed insertion
|
1
|
1
|
2
|
|
Overall Study
Planned pregnancy
|
9
|
12
|
12
|
|
Overall Study
No need for contraception
|
3
|
3
|
3
|
|
Overall Study
Could not attend visits
|
2
|
0
|
4
|
|
Overall Study
personal reason
|
6
|
1
|
1
|
Baseline Characteristics
Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
Baseline characteristics by cohort
| Measure |
LCS12
n=239 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=245 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=254 Participants
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
Total
n=738 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 5.44 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 5.31 • n=7 Participants
|
32.0 years
STANDARD_DEVIATION 5.21 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 5.31 • n=4 Participants
|
|
Sex: Female, Male
Female
|
239 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
738 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All randomized women with a successful insertion were analyzed according to the treatment actually received and were included in the FAS, which was the set used for all safety and efficacy analyses. The PPS was identical to the FAS.
The 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 under risk of getting pregnant.
Outcome measures
| Measure |
LCS12
n=239 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=245 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=254 Participants
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Pearl Index
|
0.17 Number per 100 women years
Interval 0.0 to 0.93
|
0.82 Number per 100 women years
Interval 0.27 to 1.92
|
0.00 Number per 100 women years
Interval 0.0 to 0.59
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The analysis was performed on the FAS (all subjects who had an IUS inserted).
The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.
Outcome measures
| Measure |
LCS12
n=239 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=245 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=254 Participants
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Number of Subjects With Total or Partial Expulsions
partial expulsion
|
1 participants
|
2 participants
|
4 participants
|
|
Number of Subjects With Total or Partial Expulsions
total expulsion
|
0 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: day 1 to day 90Population: The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.
Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Outcome measures
| Measure |
LCS12
n=228 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=241 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=244 Participants
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 1
Number of bleeding days (light, normal or heavy)
|
15.1 days
Standard Deviation 10.1
|
15.4 days
Standard Deviation 12.2
|
14.3 days
Standard Deviation 12.9
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 1
Number of bleeding/spotting days
|
39.9 days
Standard Deviation 18.7
|
39.2 days
Standard Deviation 19.7
|
36.6 days
Standard Deviation 19.8
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 1
Number of spotting only days
|
24.8 days
Standard Deviation 14.1
|
23.8 days
Standard Deviation 12.9
|
22.2 days
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: day 91 to day 180Population: The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.
Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Outcome measures
| Measure |
LCS12
n=225 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=230 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=239 Participants
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 2
Number of bleeding days (light, normal or heavy)
|
8.2 days
Standard Deviation 8.0
|
7.7 days
Standard Deviation 8.0
|
7.6 days
Standard Deviation 9.1
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 2
Number of bleeding/spotting days
|
22.6 days
Standard Deviation 14.3
|
21.8 days
Standard Deviation 14.3
|
21.8 days
Standard Deviation 16.8
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 2
Number of spotting only days
|
14.4 days
Standard Deviation 10.3
|
14.1 days
Standard Deviation 9.8
|
14.2 days
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: day 181 to day 270Population: The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.
Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Outcome measures
| Measure |
LCS12
n=220 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=224 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=230 Participants
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 3
Number of bleeding days (light, normal or heavy)
|
6.4 days
Standard Deviation 7.3
|
5.4 days
Standard Deviation 6.9
|
5.3 days
Standard Deviation 7.3
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 3
Number of bleeding/spotting days
|
18.3 days
Standard Deviation 12.9
|
16.7 days
Standard Deviation 12.6
|
16.8 days
Standard Deviation 14.2
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 3
Number of spotting only days
|
12.0 days
Standard Deviation 9.3
|
11.3 days
Standard Deviation 8.4
|
11.5 days
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: day 271 to day 360Population: The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.
Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Outcome measures
| Measure |
LCS12
n=217 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=218 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=225 Participants
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 4
Number of bleeding days (light, normal or heavy)
|
5.5 days
Standard Deviation 6.7
|
4.7 days
Standard Deviation 6.4
|
4.2 days
Standard Deviation 6.3
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 4
Number of bleeding/spotting days
|
16.7 days
Standard Deviation 11.4
|
15.0 days
Standard Deviation 11.6
|
15.2 days
Standard Deviation 12.3
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 4
Number of spotting only days
|
11.2 days
Standard Deviation 8.5
|
10.2 days
Standard Deviation 7.9
|
11.0 days
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: day 991 to day 1080Population: The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.
Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Outcome measures
| Measure |
LCS12
n=165 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=169 Participants
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=178 Participants
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 12
Number of bleeding days (light, normal or heavy)
|
3.6 days
Standard Deviation 6.0
|
3.0 days
Standard Deviation 4.5
|
1.9 days
Standard Deviation 3.6
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 12
Number of bleeding/spotting days
|
12.8 days
Standard Deviation 10.7
|
10.6 days
Standard Deviation 9.3
|
8.8 days
Standard Deviation 8.6
|
|
Bleeding Pattern by 90-day Reference Periods - Reference Period 12
Number of spotting only days
|
9.2 days
Standard Deviation 8.4
|
7.7 days
Standard Deviation 6.9
|
6.9 days
Standard Deviation 6.7
|
Adverse Events
LCS12
Serious events: 12 serious events
Other events: 187 other events
Deaths: 0 deaths
LCS16
Serious events: 12 serious events
Other events: 198 other events
Deaths: 0 deaths
IUS20 (Mirena)
Serious events: 16 serious events
Other events: 218 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCS12
n=239 participants at risk
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=245 participants at risk
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=254 participants at risk
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
2.0%
5/254
An additional pregnancy was not recorded as an SAE.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Surgical and medical procedures
Adhesiolysis
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Surgical and medical procedures
Mammoplasty
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Endocrine disorders
Goitre
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Eye disorders
Blindness unilateral
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
General disorders
Chest pain
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
General disorders
Hernia obstructive
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.79%
2/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Encephalitis herpes
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Pneumonia
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Pyelonephritis
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Investigations
Body temperature increased
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Nervous system disorders
Paraesthesia
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Nervous system disorders
Post-traumatic epilepsy
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/245
An additional pregnancy was not recorded as an SAE.
|
0.39%
1/254
An additional pregnancy was not recorded as an SAE.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/239
An additional pregnancy was not recorded as an SAE.
|
0.41%
1/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.42%
1/239
An additional pregnancy was not recorded as an SAE.
|
0.82%
2/245
An additional pregnancy was not recorded as an SAE.
|
0.00%
0/254
An additional pregnancy was not recorded as an SAE.
|
Other adverse events
| Measure |
LCS12
n=239 participants at risk
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
|
LCS16
n=245 participants at risk
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
|
IUS20 (Mirena)
n=254 participants at risk
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
40/239
An additional pregnancy was not recorded as an SAE.
|
20.0%
49/245
An additional pregnancy was not recorded as an SAE.
|
19.7%
50/254
An additional pregnancy was not recorded as an SAE.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.9%
19/239
An additional pregnancy was not recorded as an SAE.
|
7.8%
19/245
An additional pregnancy was not recorded as an SAE.
|
9.1%
23/254
An additional pregnancy was not recorded as an SAE.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
18/239
An additional pregnancy was not recorded as an SAE.
|
8.2%
20/245
An additional pregnancy was not recorded as an SAE.
|
8.7%
22/254
An additional pregnancy was not recorded as an SAE.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.7%
16/239
An additional pregnancy was not recorded as an SAE.
|
7.8%
19/245
An additional pregnancy was not recorded as an SAE.
|
8.3%
21/254
An additional pregnancy was not recorded as an SAE.
|
|
General disorders
Oedema
|
6.3%
15/239
An additional pregnancy was not recorded as an SAE.
|
8.6%
21/245
An additional pregnancy was not recorded as an SAE.
|
7.5%
19/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
9.6%
23/239
An additional pregnancy was not recorded as an SAE.
|
12.2%
30/245
An additional pregnancy was not recorded as an SAE.
|
8.3%
21/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Sinusitis
|
6.7%
16/239
An additional pregnancy was not recorded as an SAE.
|
8.2%
20/245
An additional pregnancy was not recorded as an SAE.
|
8.7%
22/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Influenza
|
5.9%
14/239
An additional pregnancy was not recorded as an SAE.
|
9.0%
22/245
An additional pregnancy was not recorded as an SAE.
|
7.9%
20/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Urinary tract infection
|
9.2%
22/239
An additional pregnancy was not recorded as an SAE.
|
7.3%
18/245
An additional pregnancy was not recorded as an SAE.
|
5.1%
13/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Vaginal infection
|
5.9%
14/239
An additional pregnancy was not recorded as an SAE.
|
4.5%
11/245
An additional pregnancy was not recorded as an SAE.
|
8.3%
21/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
14/239
An additional pregnancy was not recorded as an SAE.
|
5.3%
13/245
An additional pregnancy was not recorded as an SAE.
|
7.1%
18/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Bronchitis
|
3.3%
8/239
An additional pregnancy was not recorded as an SAE.
|
2.9%
7/245
An additional pregnancy was not recorded as an SAE.
|
6.3%
16/254
An additional pregnancy was not recorded as an SAE.
|
|
Infections and infestations
Vaginitis bacterial
|
5.0%
12/239
An additional pregnancy was not recorded as an SAE.
|
3.7%
9/245
An additional pregnancy was not recorded as an SAE.
|
3.1%
8/254
An additional pregnancy was not recorded as an SAE.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.5%
18/239
An additional pregnancy was not recorded as an SAE.
|
8.6%
21/245
An additional pregnancy was not recorded as an SAE.
|
9.4%
24/254
An additional pregnancy was not recorded as an SAE.
|
|
Investigations
Weight increased
|
15.9%
38/239
An additional pregnancy was not recorded as an SAE.
|
15.9%
39/245
An additional pregnancy was not recorded as an SAE.
|
12.2%
31/254
An additional pregnancy was not recorded as an SAE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
18/239
An additional pregnancy was not recorded as an SAE.
|
5.7%
14/245
An additional pregnancy was not recorded as an SAE.
|
9.1%
23/254
An additional pregnancy was not recorded as an SAE.
|
|
Nervous system disorders
Headache
|
26.4%
63/239
An additional pregnancy was not recorded as an SAE.
|
25.7%
63/245
An additional pregnancy was not recorded as an SAE.
|
32.3%
82/254
An additional pregnancy was not recorded as an SAE.
|
|
Psychiatric disorders
Mood altered
|
18.0%
43/239
An additional pregnancy was not recorded as an SAE.
|
12.2%
30/245
An additional pregnancy was not recorded as an SAE.
|
15.0%
38/254
An additional pregnancy was not recorded as an SAE.
|
|
Psychiatric disorders
Depression
|
5.4%
13/239
An additional pregnancy was not recorded as an SAE.
|
2.4%
6/245
An additional pregnancy was not recorded as an SAE.
|
3.9%
10/254
An additional pregnancy was not recorded as an SAE.
|
|
Reproductive system and breast disorders
Breast discomfort
|
21.8%
52/239
An additional pregnancy was not recorded as an SAE.
|
20.8%
51/245
An additional pregnancy was not recorded as an SAE.
|
24.4%
62/254
An additional pregnancy was not recorded as an SAE.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
8.8%
21/239
An additional pregnancy was not recorded as an SAE.
|
9.8%
24/245
An additional pregnancy was not recorded as an SAE.
|
23.6%
60/254
An additional pregnancy was not recorded as an SAE.
|
|
Reproductive system and breast disorders
Breast pain
|
8.4%
20/239
An additional pregnancy was not recorded as an SAE.
|
14.3%
35/245
An additional pregnancy was not recorded as an SAE.
|
10.6%
27/254
An additional pregnancy was not recorded as an SAE.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.9%
14/239
An additional pregnancy was not recorded as an SAE.
|
7.8%
19/245
An additional pregnancy was not recorded as an SAE.
|
7.1%
18/254
An additional pregnancy was not recorded as an SAE.
|
|
Skin and subcutaneous tissue disorders
Acne
|
26.8%
64/239
An additional pregnancy was not recorded as an SAE.
|
24.9%
61/245
An additional pregnancy was not recorded as an SAE.
|
28.7%
73/254
An additional pregnancy was not recorded as an SAE.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
6.7%
16/239
An additional pregnancy was not recorded as an SAE.
|
7.3%
18/245
An additional pregnancy was not recorded as an SAE.
|
8.3%
21/254
An additional pregnancy was not recorded as an SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor is interested in the publication of the results of every study. As some of the information concerning the study drug and the sponsor's development activities may be strictly confidential, any publication manuscript (including conference contributions, etc.) must first be reviewed by the sponsor before its submission or presentation.
- Publication restrictions are in place
Restriction type: OTHER