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OpenTrials
Completed

NCT Number: NCT01958684

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

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

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel IUS (Mirena, BAY86-5028)

Drug

LNG-IUS once inserted will be effective for 5 years.

Other names: Mirena Group

Copper-IUD

Device

Copper-IUD once inserted will be effective for more than 10 years.

Other names: Cu-IUD Group

Primary outcomes

  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 outcomes

  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.)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD

Acronym: POST

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 9, 2013
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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