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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002291-42 | EudraCT Number | ||
| 308901 | Other Identifier | Company internal |
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The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Although the title of the study describes "open", it was in fact single-blinded.
Issues on side effects are addressed in the Adverse Event section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCS12 | Experimental | Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro |
|
| LCS16 | Experimental | Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro |
|
| IUS20 (Mirena) | Active Comparator | Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUS (BAY86-5028, G04209B) | Drug | Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pearl Index | 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. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Total or Partial Expulsions | 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. | Up to 3 years |
| Bleeding Pattern by 90-day Reference Periods - Reference Period 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Espoo | 02100 | Finland | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22222193 | Result | Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012 Mar;97(3):616-22.e1-3. doi: 10.1016/j.fertnstert.2011.12.003. Epub 2012 Jan 4. | |
| 24726226 | Result |
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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).
Parous or nulliparous women in good general health and in need of contraception were recruited from medical clinics between April and Nov 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | LCS12 | Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro |
| FG001 | LCS16 | Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Levonorgestrel IUS (BAY86-5028, G04209C) | Drug | Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years |
|
| Levonorgestrel IUS (Mirena, BAY86-5028) | Drug | Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years |
|
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. |
| day 1 to day 90 |
| Bleeding Pattern by 90-day Reference Periods - Reference Period 2 | 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. | day 91 to day 180 |
| Bleeding Pattern by 90-day Reference Periods - Reference Period 3 | 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. | day 181 to day 270 |
| Bleeding Pattern by 90-day Reference Periods - Reference Period 4 | 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. | day 271 to day 360 |
| Bleeding Pattern by 90-day Reference Periods - Reference Period 12 | 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. | day 991 to day 1080 |
| Helsinki |
| 00100 |
| Finland |
| Joensuu | 80100 | Finland |
| Jyväskylä | 40620 | Finland |
| Kotka | 48100 | Finland |
| Kuopio | 70110 | Finland |
| Lahti | 15110 | Finland |
| Oulu | 90100 | Finland |
| Oulu | 90220 | Finland |
| Oulu | 90570 | Finland |
| Tampere | 33100 | Finland |
| Turku | 20100 | Finland |
| Turku | 20520 | Finland |
| Turku | 20540 | Finland |
| Békéscsaba | 5600 | Hungary |
| Eger | 3300 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Szeged | 6725 | Hungary |
| Drammen | 3001 | Norway |
| Elverum | 2403 | Norway |
| Kolbotn | 1411 | Norway |
| Larvik | 3264 | Norway |
| Oslo | 0309 | Norway |
| Trondheim | 7014 | Norway |
| Gothenburg | 411 35 | Sweden |
| Huddinge | 14186 | Sweden |
| Kalmar | 39231 | Sweden |
| Luleå | 972 33 | Sweden |
| Norrköping | 602 22 | Sweden |
| Örebro | 701 46 | Sweden |
| Stockholm | S-171 76 | Sweden |
| Umeå | 90185 | Sweden |
| Chesterfield | Derbyshire | S40 4TF | United Kingdom |
| Sheffield | South Yorkshire | S1 2PJ | United Kingdom |
| Chesterfield | S40 1SX | United Kingdom |
| Apter D, Gemzell-Danielsson K, Hauck B, Rosen K, Zurth C. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014 Jun;101(6):1656-62.e1-4. doi: 10.1016/j.fertnstert.2014.03.004. Epub 2014 Apr 14. |
| FG002 | IUS20 (Mirena) | Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro |
| Subjects Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LCS12 | Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro |
| BG001 | LCS16 | Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro |
| BG002 | IUS20 (Mirena) | Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Whilst 742 subjects were randomized, only 738 were treated. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pearl Index | 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. | 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. | Posted | Median | 95% Confidence Interval | Number per 100 women years | Up to 3 years |
|
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| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Total or Partial Expulsions | 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. | The analysis was performed on the FAS (all subjects who had an IUS inserted). | Posted | Number | participants | Up to 3 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Bleeding Pattern by 90-day Reference Periods - Reference Period 1 | 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. | The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both. | Posted | Mean | Standard Deviation | days | day 1 to day 90 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Bleeding Pattern by 90-day Reference Periods - Reference Period 2 | 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. | The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both. | Posted | Mean | Standard Deviation | days | day 91 to day 180 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Bleeding Pattern by 90-day Reference Periods - Reference Period 3 | 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. | The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both. | Posted | Mean | Standard Deviation | days | day 181 to day 270 |
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| Secondary | Bleeding Pattern by 90-day Reference Periods - Reference Period 4 | 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. | The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both. | Posted | Mean | Standard Deviation | days | day 271 to day 360 |
|
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| Secondary | Bleeding Pattern by 90-day Reference Periods - Reference Period 12 | 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. | The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both. | Posted | Mean | Standard Deviation | days | day 991 to day 1080 |
|
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An additional pregnancy was not recorded as an SAE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCS12 | Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro | 12 | 239 | 187 | 239 | ||
| EG001 | LCS16 | Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro | 12 | 245 | 198 | 245 | ||
| EG002 | IUS20 (Mirena) | Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro | 16 | 254 | 218 | 254 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Goitre | Endocrine disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Blindness unilateral | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Hernia obstructive | General disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Biliary dyskinesia | Hepatobiliary disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Cervicitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Encephalitis herpes | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Pelvic inflammatory disease | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Brain contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
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| Skull fractured base | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
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| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
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| Body temperature increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
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| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
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| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
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| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
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| Phaeochromocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Post-traumatic epilepsy | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (11.1) | Non-systematic Assessment |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (11.1) | Non-systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (11.1) | Non-systematic Assessment |
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| Alcohol abuse | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Abdominal hernia repair | Surgical and medical procedures | MedDRA (11.1) | Non-systematic Assessment |
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| Adhesiolysis | Surgical and medical procedures | MedDRA (11.1) | Non-systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | MedDRA (11.1) | Non-systematic Assessment |
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| Mammoplasty | Surgical and medical procedures | MedDRA (11.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Vaginitis bacterial | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Breast discomfort | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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