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

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel IUS (Mirena, BAY86-5028); Device: Copper-IUD

• Registration Number: NCT01958684
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 512

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel IUS (Mirena, BAY86-5028)	The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h)
Group 2	Copper-IUD	Copper IUDs with different shape and with or without drugs

Primary Outcome Measures

Name	Time	Method
The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion	Months 4 to 6	The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day.

Secondary Outcome Measures

Name	Time	Method
Menstrual bleeding intensity	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
Abortion related bleeding days	up to 1 month
Time to the first menstrual bleeding following abortion	up to 2 months	This data will be calculated by days
Reasons for discontinuation of Mirena and Cu-IUD	Up to 6 months	It will be calculated by percentage
Participants continuation rates of Mirena and Cu-IUD	up to 6 months
Percentage of participants with adverse events	Up to 6 months	Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)
Participants satisfaction rates of Mirena and Cu-IUD	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