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:
EudraCT Number:
Not Available
EU CT 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
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
| Locations | |
|---|---|
Locations Investigative Site Many Locations, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A non-interventional study to observe the bleeding pattern of LNG-IUS inserted immediately after Surgical abortion compared with Copper IUD
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortionThe 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day.Timeframe: Months 4 to 6
Secondary Outcome
- Menstrual bleeding intensityIt will be captured by patient dairy and measured by subjective scale as below. - No bleeding - Light bleeding - Normal bleeding - Heavy bleeding - Very heavy bleedingTimeframe: up to 6 months
- Abortion related bleeding daysTimeframe: up to 1 month
- Time to the first menstrual bleeding following abortionThis data will be calculated by daysTimeframe: up to 2 months
- Participants continuation rates of Mirena and Cu-IUDTimeframe: up to 6 months
- Reasons for discontinuation of Mirena and Cu-IUDIt will be calculated by percentageTimeframe: Up to 6 months
- Participants satisfaction rates of Mirena and Cu-IUDIt will be captured by satisfaction scale as below. - Very satisfied - Rather satisfied - neither satisfied nor dissatisfied - Rather unsatisfied - Very unsatisfiedTimeframe: Up to 6 months
- Percentage of participants with adverse eventsAdverse events included: Pelvic inflammatory disease, Expulsion and Others.)Timeframe: Up to 6 months
Additional Information
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