Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion (POST)
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|ClinicalTrials.gov Identifier: NCT01958684|
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : October 16, 2015
|Condition or disease||Intervention/treatment|
|Contraception||Drug: Levonorgestrel IUS (Mirena, BAY86-5028) Device: Copper-IUD|
|Study Type :||Observational|
|Actual Enrollment :||512 participants|
|Official Title:||A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD|
|Study Start Date :||October 2013|
|Primary Completion Date :||October 2014|
|Study Completion Date :||October 2014|
The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h)
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
LNG-IUS once inserted will be effective for 5 years.
Other Name: Mirena Group
Copper IUDs with different shape and with or without drugs
Copper-IUD once inserted will be effective for more than 10 years.
Other Name: Cu-IUD Group
- The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion [ Time Frame: Months 4 to 6 ]The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day.
- Menstrual bleeding intensity [ Time Frame: up to 6 months ]
It will be captured by patient dairy and measured by subjective scale as below.
- No bleeding
- Light bleeding
- Normal bleeding
- Heavy bleeding
- Very heavy bleeding
- Abortion related bleeding days [ Time Frame: up to 1 month ]
- Time to the first menstrual bleeding following abortion [ Time Frame: up to 2 months ]This data will be calculated by days
- Participants continuation rates of Mirena and Cu-IUD [ Time Frame: up to 6 months ]
- Reasons for discontinuation of Mirena and Cu-IUD [ Time Frame: Up to 6 months ]It will be calculated by percentage
- Participants satisfaction rates of Mirena and Cu-IUD [ Time Frame: Up to 6 months ]
It will be captured by satisfaction scale as below.
- Very satisfied
- Rather satisfied
- neither satisfied nor dissatisfied
- Rather unsatisfied
- Very unsatisfied
- Percentage of participants with adverse events [ Time Frame: Up to 6 months ]Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958684
|Many Locations, China|
|Study Director:||Bayer Study Director||Bayer|