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Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185380
First Posted: September 16, 2005
Last Update Posted: June 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
Results First Submitted: December 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition: Contraception
Interventions: Drug: Levonorgestrel IUS (BAY86-5028, G04209B)
Drug: Levonorgestrel IUS (BAY86-5028, G04209C)
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Parous or nulliparous women in good general health and in need of contraception were recruited from medical clinics between April and Nov 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    LCS12   LCS16   IUS20 (Mirena)
STARTED   240   246   256 
Subjects Received Treatment   239   245   254 
COMPLETED   174   174   182 
NOT COMPLETED   66   72   74 
Adverse Event                41                43                48 
Lost to Follow-up                0                4                3 
Pregnancy                1                4                0 
Protocol Violation                2                2                1 
Withdrawal by Subject                1                2                0 
Failed insertion                1                1                2 
Planned pregnancy                9                12                12 
No need for contraception                3                3                3 
Could not attend visits                2                0                4 
personal reason                6                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   LCS12   LCS16   IUS20 (Mirena)   Total 
Overall Participants Analyzed 
[Units: Participants]
 239   245   254   738 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.2  (5.44)   32.1  (5.31)   32.0  (5.21)   32.1  (5.31) 
Gender [1] 
[Units: Participants]
       
Female   239   245   254   738 
Male   0   0   0   0 
[1] Whilst 742 subjects were randomized, only 738 were treated.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pearl Index   [ Time Frame: Up to 3 years ]

2.  Secondary:   Number of Subjects With Total or Partial Expulsions   [ Time Frame: Up to 3 years ]

3.  Secondary:   Bleeding Pattern by 90-day Reference Periods - Reference Period 1   [ Time Frame: day 1 to day 90 ]

4.  Secondary:   Bleeding Pattern by 90-day Reference Periods - Reference Period 2   [ Time Frame: day 91 to day 180 ]

5.  Secondary:   Bleeding Pattern by 90-day Reference Periods - Reference Period 3   [ Time Frame: day 181 to day 270 ]

6.  Secondary:   Bleeding Pattern by 90-day Reference Periods - Reference Period 4   [ Time Frame: day 271 to day 360 ]

7.  Secondary:   Bleeding Pattern by 90-day Reference Periods - Reference Period 12   [ Time Frame: day 991 to day 1080 ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description An additional pregnancy was not recorded as an SAE.

Reporting Groups
  Description
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

Serious Adverse Events
    LCS12   LCS16   IUS20 (Mirena)
Total, Serious Adverse Events       
# participants affected / at risk   12/239 (5.02%)   12/245 (4.90%)   16/254 (6.30%) 
Endocrine disorders       
Goitre * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Eye disorders       
Blindness unilateral * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Gastroduodenal ulcer * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Gastrooesophageal reflux disease * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Vomiting * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
General disorders       
Chest pain * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   0/254 (0.00%) 
Hernia obstructive * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Hepatobiliary disorders       
Biliary dyskinesia * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   0/254 (0.00%) 
Cholecystitis * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Cholecystitis chronic * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   0/254 (0.00%) 
Infections and infestations       
Appendicitis * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   2/254 (0.79%) 
Cervicitis * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Clostridium difficile colitis * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Encephalitis herpes * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Pelvic inflammatory disease * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   1/254 (0.39%) 
Pneumonia * 1       
# participants affected / at risk   1/239 (0.42%)   1/245 (0.41%)   0/254 (0.00%) 
Post procedural infection * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Pyelonephritis * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Injury, poisoning and procedural complications       
Brain contusion * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Post procedural haematoma * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   1/254 (0.39%) 
Post procedural haemorrhage * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Road traffic accident * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Skull fractured base * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Subdural haematoma * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Traumatic intracranial haemorrhage * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Investigations       
Body temperature increased * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Musculoskeletal and connective tissue disorders       
Arthritis reactive * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   0/254 (0.00%) 
Intervertebral disc protrusion * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   1/254 (0.39%) 
Rotator cuff syndrome * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   0/254 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Benign breast neoplasm * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Leiomyoma * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   0/254 (0.00%) 
Malignant melanoma * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Ovarian germ cell teratoma benign * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Phaeochromocytoma * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Nervous system disorders       
Paraesthesia * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Post-traumatic epilepsy * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   0/254 (0.00%) 
Ectopic pregnancy * 1       
# participants affected / at risk   1/239 (0.42%)   2/245 (0.82%)   0/254 (0.00%) 
Pregnancy * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   0/254 (0.00%) 
Psychiatric disorders       
Alcohol abuse * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Reproductive system and breast disorders       
Cervical dysplasia * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Ovarian cyst * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   5/254 (1.97%) 
Vaginal haemorrhage * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1       
# participants affected / at risk   0/239 (0.00%)   1/245 (0.41%)   1/254 (0.39%) 
Surgical and medical procedures       
Abdominal hernia repair * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Adhesiolysis * 1       
# participants affected / at risk   1/239 (0.42%)   0/245 (0.00%)   0/254 (0.00%) 
Knee arthroplasty * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
Mammoplasty * 1       
# participants affected / at risk   0/239 (0.00%)   0/245 (0.00%)   1/254 (0.39%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (11.1)




  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description An additional pregnancy was not recorded as an SAE.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
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

Other Adverse Events
    LCS12   LCS16   IUS20 (Mirena)
Total, Other (not including serious) Adverse Events       
# participants affected / at risk   187/239 (78.24%)   198/245 (80.82%)   218/254 (85.83%) 
Gastrointestinal disorders       
Abdominal distension * 1       
# participants affected / at risk   40/239 (16.74%)   49/245 (20.00%)   50/254 (19.69%) 
Abdominal pain * 1       
# participants affected / at risk   19/239 (7.95%)   19/245 (7.76%)   23/254 (9.06%) 
Nausea * 1       
# participants affected / at risk   18/239 (7.53%)   20/245 (8.16%)   22/254 (8.66%) 
Abdominal pain lower * 1       
# participants affected / at risk   16/239 (6.69%)   19/245 (7.76%)   21/254 (8.27%) 
General disorders       
Oedema * 1       
# participants affected / at risk   15/239 (6.28%)   21/245 (8.57%)   19/254 (7.48%) 
Infections and infestations       
Vulvovaginal candidiasis * 1       
# participants affected / at risk   23/239 (9.62%)   30/245 (12.24%)   21/254 (8.27%) 
Sinusitis * 1       
# participants affected / at risk   16/239 (6.69%)   20/245 (8.16%)   22/254 (8.66%) 
Influenza * 1       
# participants affected / at risk   14/239 (5.86%)   22/245 (8.98%)   20/254 (7.87%) 
Urinary tract infection * 1       
# participants affected / at risk   22/239 (9.21%)   18/245 (7.35%)   13/254 (5.12%) 
Vaginal infection * 1       
# participants affected / at risk   14/239 (5.86%)   11/245 (4.49%)   21/254 (8.27%) 
Nasopharyngitis * 1       
# participants affected / at risk   14/239 (5.86%)   13/245 (5.31%)   18/254 (7.09%) 
Bronchitis * 1       
# participants affected / at risk   8/239 (3.35%)   7/245 (2.86%)   16/254 (6.30%) 
Vaginitis bacterial * 1       
# participants affected / at risk   12/239 (5.02%)   9/245 (3.67%)   8/254 (3.15%) 
Injury, poisoning and procedural complications       
Procedural pain * 1       
# participants affected / at risk   18/239 (7.53%)   21/245 (8.57%)   24/254 (9.45%) 
Investigations       
Weight increased * 1       
# participants affected / at risk   38/239 (15.90%)   39/245 (15.92%)   31/254 (12.20%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1       
# participants affected / at risk   18/239 (7.53%)   14/245 (5.71%)   23/254 (9.06%) 
Nervous system disorders       
Headache * 1       
# participants affected / at risk   63/239 (26.36%)   63/245 (25.71%)   82/254 (32.28%) 
Psychiatric disorders       
Mood altered * 1       
# participants affected / at risk   43/239 (17.99%)   30/245 (12.24%)   38/254 (14.96%) 
Depression * 1       
# participants affected / at risk   13/239 (5.44%)   6/245 (2.45%)   10/254 (3.94%) 
Reproductive system and breast disorders       
Breast discomfort * 1       
# participants affected / at risk   52/239 (21.76%)   51/245 (20.82%)   62/254 (24.41%) 
Ovarian cyst * 1       
# participants affected / at risk   21/239 (8.79%)   24/245 (9.80%)   60/254 (23.62%) 
Breast pain * 1       
# participants affected / at risk   20/239 (8.37%)   35/245 (14.29%)   27/254 (10.63%) 
Dysmenorrhoea * 1       
# participants affected / at risk   14/239 (5.86%)   19/245 (7.76%)   18/254 (7.09%) 
Skin and subcutaneous tissue disorders       
Acne * 1       
# participants affected / at risk   64/239 (26.78%)   61/245 (24.90%)   73/254 (28.74%) 
Seborrhoea * 1       
# participants affected / at risk   16/239 (6.69%)   18/245 (7.35%)   21/254 (8.27%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (11.1)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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