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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01958684
First received: October 7, 2013
Last updated: August 10, 2014
Last verified: August 2014
  Purpose

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Time to the first menstrual bleeding following abortion [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
    This data will be calculated by days

  • Participants continuation rates of Mirena and Cu-IUD [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Reasons for discontinuation of Mirena and Cu-IUD [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    It will be calculated by percentage

  • Participants satisfaction rates of Mirena and Cu-IUD [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)


Estimated Enrollment: 500
Study Start Date: October 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  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 ClinicalTrials.gov identifier: NCT01958684

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01958684     History of Changes
Other Study ID Numbers: 16954, MA1310CN
Study First Received: October 7, 2013
Last Updated: August 10, 2014
Health Authority: China: None

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

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

ClinicalTrials.gov processed this record on August 19, 2014