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Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion (POST)

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: October 7, 2013
Last updated: October 15, 2015
Last verified: October 2015
To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.

Condition Intervention
Contraception Drug: Levonorgestrel IUS (Mirena, BAY86-5028) Device: Copper-IUD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.)

Enrollment: 512
Study Start Date: October 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
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
Group 2
Copper IUDs with different shape and with or without drugs
Device: Copper-IUD
Copper-IUD once inserted will be effective for more than 10 years.
Other Name: Cu-IUD Group


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects should go through the surgical abortion should meet both inclusion and exclusion criteria. And they are willing to sign an informed consent. And all recruitment should be conducted after the decision of treatment.

Inclusion Criteria:

  • Reproductive women in good general health and requesting long-term contraception
  • Applied the Cu-IUD or LNG-IUS immediately after first trimester surgical abortion
  • History of regular cyclic menstrual periods
  • Written ICF was obtained

Exclusion Criteria:

  • Suspected septic abortion and incomplete abortion, as well as missed abortion
  • The contraindications and warnings of the respective Summary of Product Characteristics of Mirena or prescribing information of Cu-IUDs must be followed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01958684

Many Locations, China
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01958684     History of Changes
Other Study ID Numbers: 16954
MA1310CN ( Other Identifier: company internal )
Study First Received: October 7, 2013
Last Updated: October 15, 2015

Keywords provided by Bayer:
Bleeding pattern

Additional relevant MeSH terms:
Pathologic Processes
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Growth Substances processed this record on September 18, 2017