check_circleStudy Completed

contraception

Bayer Identifier:

16954

ClinicalTrials.gov Identifier:

NCT01958684

EudraCT Number:

Not Available

EU CT Number:

Not Available
Bleeding pattern difference between levonorgestrel intrauterine system (LNG-IUS) and Copper intrauterine devices (IUDs) immediately inserted after abortion

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
512
Trial Dates
October 2013 - October 2014
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, China

Primary Outcome

  • The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion
    The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day.
    date_rangeTime Frame:
    Months 4 to 6
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    Safety Issue:
    No

Secondary Outcome

  • Menstrual bleeding intensity
    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
    date_rangeTime Frame:
    up to 6 months
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    Safety Issue:
    No
  • Abortion related bleeding days
    date_rangeTime Frame:
    up to 1 month
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    Safety Issue:
    No
  • Time to the first menstrual bleeding following abortion
    This data will be calculated by days
    date_rangeTime Frame:
    up to 2 months
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    Safety Issue:
    No
  • Participants continuation rates of Mirena and Cu-IUD
    date_rangeTime Frame:
    up to 6 months
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    Safety Issue:
    No
  • Reasons for discontinuation of Mirena and Cu-IUD
    It will be calculated by percentage
    date_rangeTime Frame:
    Up to 6 months
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    Safety Issue:
    No
  • Participants satisfaction rates of Mirena and Cu-IUD
    It will be captured by satisfaction scale as below. - Very satisfied - Rather satisfied - neither satisfied nor dissatisfied - Rather unsatisfied - Very unsatisfied
    date_rangeTime Frame:
    Up to 6 months
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    Safety Issue:
    No
  • Percentage of participants with adverse events
    Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)
    date_rangeTime Frame:
    Up to 6 months
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    Safety Issue:
    Yes

Trial design

A non-interventional study to observe the bleeding pattern of LNG-IUS inserted immediately after Surgical abortion compared with Copper IUD
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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