Trial Condition(s):

Contraception

Bleeding pattern difference between levonorgestrel intrauterine system (LNG-IUS) and Copper intrauterine devices (IUDs) immediately inserted after abortion (POST)

Bayer Identifier:

16954

ClinicalTrials.gov Identifier:

NCT01958684

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
512
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, China

Status
Completed
 

Trial Design