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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel IUS (Mirena, BAY86-5028) (Drug); Copper-IUD (Device)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion

Secondary outcome:

Menstrual bleeding intensity

Abortion related bleeding days

Time to the first menstrual bleeding following abortion

Participants continuation rates of Mirena and Cu-IUD

Reasons for discontinuation of Mirena and Cu-IUD

Participants satisfaction rates of Mirena and Cu-IUD

Percentage of participants with adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Many Locations, China
Additional Information

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Starting date: October 2013
Last updated: April 13, 2015

Page last updated: August 23, 2015

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