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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00185380
First received: September 13, 2005
Last updated: May 21, 2014
Last verified: May 2014
Results First Received: December 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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  
Number of Participants  
[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


  Other Adverse Events


  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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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185380     History of Changes
Other Study ID Numbers: 91412, 2004-002291-42, 308901
Study First Received: September 13, 2005
Results First Received: December 10, 2009
Last Updated: May 21, 2014
Health Authority: Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Lithuania: State Medicine Control Agency - Ministry of Health
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency