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

October 15, 2015 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

512

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Many Locations, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Cu-IUD Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Months 4 to 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 months
Abortion related bleeding days
Time Frame: up to 1 month
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
up to 2 months
Participants continuation rates of Mirena and Cu-IUD
Time Frame: up to 6 months
up to 6 months
Reasons for discontinuation of Mirena and Cu-IUD
Time Frame: Up to 6 months
It will be calculated by percentage
Up to 6 months
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
Up to 6 months
Percentage of participants with adverse events
Time Frame: Up to 6 months
Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16954
  • MA1310CN (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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