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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
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.

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

Study Type : Observational
Actual Enrollment : 512 participants
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
Study Start Date : October 2013
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Abortion related bleeding days [ Time Frame: up to 1 month ]
  3. Time to the first menstrual bleeding following abortion [ Time Frame: up to 2 months ]
    This data will be calculated by days

  4. Participants continuation rates of Mirena and Cu-IUD [ Time Frame: up to 6 months ]
  5. Reasons for discontinuation of Mirena and Cu-IUD [ Time Frame: Up to 6 months ]
    It will be calculated by percentage

  6. 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

  7. Percentage of participants with adverse events [ Time Frame: Up to 6 months ]
    Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)



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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.
Criteria

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

Information from the National Library of Medicine

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


Locations
China
Many Locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01958684     History of Changes
Other Study ID Numbers: 16954
MA1310CN ( Other Identifier: company internal )
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Bayer:
Bleeding pattern
LNG-IUS
Cu-IUD
postabortion

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Levonorgestrel
Copper
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Growth Substances