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

Contraception Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958684
• Other study ID #: 16954
• Secondary ID: MA1310CN
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: October 15, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: None
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel IUS (Mirena, BAY86-5028)
LNG-IUS once inserted will be effective for 5 years.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion	The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day.	Months 4 to 6	No
Secondary	Menstrual bleeding intensity	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	No
Secondary	Abortion related bleeding days		up to 1 month	No
Secondary	Time to the first menstrual bleeding following abortion	This data will be calculated by days	up to 2 months	No
Secondary	Participants continuation rates of Mirena and Cu-IUD		up to 6 months	No
Secondary	Reasons for discontinuation of Mirena and Cu-IUD	It will be calculated by percentage	Up to 6 months	No
Secondary	Participants satisfaction rates of Mirena and Cu-IUD	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	No
Secondary	Percentage of participants with adverse events	Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)	Up to 6 months	Yes

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